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Aims: To describe the prevalence of use of breastmilk and explore demographic characteristics and clinical outcomes associated with breastmilk provision in infants born <29 weeks' gestational age in Australia, New Zealand and Singapore., Methods: This is a secondary analysis of data from a randomised controlled trial, which enrolled 1273 infants in 13 neonatal units across Australia, New Zealand and Singapore from 2012 to 2015. Infants were classified as formula-fed, donor milk-fed or mother's milk-fed at their first enteral feed and separately, at hospital discharge., Results: The percentage of infants receiving mother's own milk differed between centres both at first feed (79% to 100%), and at hospital discharge (47.1% to 71.6%). Aboriginal, Torres Strait Islander and Southeast Asian heritage, drug use and smoking were associated with lower rates of fully breastmilk feeding at hospital discharge. There was no significant difference in growth outcomes, length of stay and feeding tolerance between feeding groups., Conclusions: Achieving high breastmilk feeding rates at hospital discharge for all preterm infants born <29 weeks' gestational age at hospital discharge is possible; however, targeted support for mothers who are Indigenous, Southeast Asian and/or using recreational drugs and/or smoking and/or experiencing social disadvantage may be needed. A better understanding and shared knowledge of practice variations within neonatal units with high breastfeeding rates could improve breastmilk access and equity for preterm infants., Australian New Zealand Clinical Trials Registry: ACTRN12612000503820., (© 2024 The Author(s). Journal of Paediatrics and Child Health published by John Wiley & Sons Australia, Ltd on behalf of Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Importance: Maternal milk feeding may have unique long-term neurodevelopmental benefits in very preterm infants., Objective: To examine the extent to which maternal milk feeding after very preterm birth is associated with cognitive, academic, and behavioral outcomes at school age., Design, Setting, and Participants: This prospective cohort study assessed 586 infants born at less than 33 weeks' gestation at 5 Australian perinatal centers and enrolled in the Docosahexaenoic Acid for Improvement of Neurodevelopmental Outcomes study (January 1, 2001, to December 31, 2005) who were evaluated at a corrected age of 7 years. The statistical analysis was completed on January 19, 2022., Exposures: Maternal milk intake, including mean volume (milliliters per kilogram per day) during neonatal hospitalization and total duration (in months)., Main Outcomes and Measures: Neurodevelopmental outcomes at 7 years of age were (1) IQ (Wechsler Abbreviated Scale of Intelligence), (2) academic achievement (Wide Range Achievement Test, Fourth Edition), (3) symptoms of attention-deficit/hyperactivity disorder (ADHD) (Conners Third Edition ADHD Index, parent reported), (4) executive function (Behavior Rating Inventory of Executive Functioning, parent reported), and (5) behavior (Strengths and Difficulties Questionnaire, parent reported)., Results: A total of 586 infants (mean [SD] gestational age at birth, 29.6 [2.3] weeks; 314 male [53.6%]) born to 486 mothers (mean [SD] age, 30.6 [5.5] years; 447 [92.0%] White) were included. Mean (SD) maternal milk intake in the neonatal intensive care unit was 99 (48) mL/kg daily, and mean (SD) maternal milk duration was 5.1 (5.4) months. Mean (SD) full-scale IQ was 98.5 (13.3) points. After covariate adjustment, higher maternal milk intake during the neonatal hospitalization was associated with higher performance IQ (0.67 points per additional 25 mL/kg daily; 95% CI, 0.10-1.23 points), reading scores (1.14 points per 25 mL/kg daily; 95% CI, 0.39-1.89 points), and math scores (0.76 points per 25 mL/kg daily; 95% CI, 0.14-1.37 points) and fewer ADHD symptoms (-1.08 points per 25 mL/kg daily; 95% CI, -1.96 to -0.20 points). Longer duration of maternal milk intake was associated with higher reading (0.33 points per additional month; 95% CI, 0.03-0.63 points), spelling (0.31 points per month; 95% CI, 0.01-0.62 points), and math (0.30 points per month; 95% CI, 0.03-0.58 points) scores. Maternal milk was not associated with improved full-scale IQ, verbal IQ, executive function, or behavior. Most associations were stronger among infants born at lower gestational ages, particularly less than 30 weeks (interaction P values <.01)., Conclusions and Relevance: In this cohort study of preterm infants, maternal milk feeding during the neonatal hospitalization and after discharge were associated with better school-age performance IQ and academic achievement and with a reduction in ADHD symptoms, particularly among infants born at less than 30 weeks' gestation.

Aim: To assess effects of early versus delayed introduction of human milk fortification in preterm infants., Methods: We searched Cochrane Central Register of Controlled Trials, MEDLINE, Embase, PubMed and CINAHL for randomised controlled trials evaluating start time for human milk fortification in preterm infants (March 2020). Two authors assessed trial eligibility and risk of bias, extracted data and assessed evidence certainty., Results: We identified 1307 publications and included three trials (378 infants). Meta-analysis comparing fortification commencing at an enteral feed volume of ≤40 mL/kg/day versus ≥75 mL/kg/day, showed little to no difference in rates of necrotising enterocolitis (3 trials), sepsis (3 trials), feeding intolerance (2 trials) (low-quality evidence) and infant growth (1 trial, very low-quality evidence)., Conclusions: Whether early introduction of fortification, at an enteral feed volume of ≤40 mL versus delayed at ≥75 mL/kg/day improves growth or influences adverse feeding outcomes is very uncertain., (© 2021 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Human milk (HM) is the gold standard for feeding infants but has been associated with slower growth in preterm infants compared with preterm formula. This systematic review and meta-analysis summarises the post-1990 literature to examine the effect of HM feeding on growth during the neonatal admission of preterm infants with birth weight ≤1500 g and/or born ≤28 weeks' gestation. Medline, PubMed, CINAHL, and Scopus were searched, and comparisons were grouped as exclusive human milk (EHM) vs. exclusive preterm formula (EPTF), any HM vs. EPTF, and higher vs. lower doses of HM. We selected studies that used fortified HM and compared that with a PTF; studies comparing unfortified HM and term formula were excluded. Experimental and observational studies were pooled separately. The GRADE system was used to evaluate risk of bias and certainty of evidence. Forty-four studies were included with 37 ( n = 9963 infants) included in the meta-analyses. In general, due to poor quality studies, evidence of the effect of any HM feeds or higher versus lower doses of HM was inconclusive. There was a possible effect that lower doses of HM compared with higher doses of HM improved weight gain during the hospital admission, and separately, a possible effect of increased head circumference growth in infants fed EPTF vs. any HM. The clinical significance of this is unclear. There was insufficient evidence to determine the effects of an exclusive HM diet on any outcomes.

Objective: To conduct a systematic review and meta-analysis of the efficacy and safety of fortification of human milk with human milk-based fortifier versus cow's milk-based fortifier for use in preterm and/or very low birthweight infants., Design: Randomised or quasi-randomised controlled trials comparing the effect of human milk fortification with human milk-based milk fortifier versus cow's milk-based fortifier in infants born <34 weeks' gestation and/or with birth weight <1500 g were identified by searching databases, clinical trial registries and reference lists until 5 November 2019. Two authors independently extracted data and assessed evidence quality. Meta-analyses were conducted using fixed or random effects models, as appropriate., Main Outcome Measures: Necrotising enterocolitis (Bell's stage II or higher) and late-onset sepsis., Results: Of 863 unique records identified, 16 full-text trials were screened and 2 trials involving 334 infants were included. Primary outcome data were available for 332 infants. Use of human milk-based fortifier compared with cow's milk-based fortifier reduced the risk of necrotising enterocolitis (risk ratio 0.47, 95% CI 0.22 to 0.98). There was no clear evidence of an effect on late-onset sepsis or any other outcomes. The quality of evidence was low to very low due to imprecision and lack of blinding in one study., Conclusions: Findings suggest that there is a reduction in the incidence of necrotising enterocolitis with human milk-based fortifiers compared with cow's milk-based fortifiers. The overall quality of evidence is low. Further appropriately powered trials are required before this intervention can be routinely recommended for preterm infants., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Human milk alone may provide inadequate amounts of protein to meet the growth requirements of preterm infants because of restrictions in the amount of fluid they can tolerate. It has become common practice to feed preterm infants with breast milk fortified with protein and other nutrients but there is debate about the optimal concentration of protein in commercially available fortifiers., Objectives: To compare the effects of different protein concentrations in human milk fortifier, fed to preterm infants, on growth and neurodevelopment., Search Methods: We used the standard search strategy of Cochrane Neonatal to search CENTRAL (2019, Issue 8), Ovid MEDLINE and CINAHL on 15 August 2019. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials and quasi-randomised trials., Selection Criteria: We included all published and unpublished randomised, quasi-randomised and cluster-randomised trials comparing two different concentrations of protein in human milk fortifier. We included preterm infants (less than 37 weeks' gestational age). Participants may have been exclusively fed human milk or have been supplemented with formula. The concentration of protein was classified as low (< 1g protein/100 mL expressed breast milk (EBM)), moderate (≥ 1g to < 1.4g protein/100 mL EBM) or high (≥ 1.4g protein/100 mL EBM). We excluded trials that compared two protein concentrations that fell within the same category., Data Collection and Analysis: We undertook data collection and analyses using the standard methods of Cochrane Neonatal. Two review authors independently evaluated trials. Primary outcomes included growth, neurodevelopmental outcome and mortality. Data were synthesised using risk ratios (RR), risk differences and mean differences (MD), with 95% confidence intervals (CI). We used the GRADE approach to assess the certainty of the evidence., Main Results: We identified nine trials involving 861 infants. There is one trial awaiting classification, and nine ongoing trials. The trials were mostly conducted in infants born < 32 weeks' gestational age or < 1500 g birthweight, or both. All used a fortifier derived from bovine milk. Two trials fed infants exclusively with mother's own milk, three trials gave supplementary feeds with donor human milk and four trials supplemented with preterm infant formula. Overall, trials were small but generally at low or unclear risk of bias. High versus moderate protein concentration of human milk fortifier There was moderate certainty evidence that a high protein concentration likely increased in-hospital weight gain compared to moderate concentration of human milk fortifier (MD 0.66 g/kg/day, 95% CI 0.51 to 0.82; trials = 6, participants = 606). The evidence was very uncertain about the effect of high versus moderate protein concentration on length gain (MD 0.01 cm/week, 95% CI -0.01 to 0.03; trials = 5, participants = 547; very low certainty evidence) and head circumference gain (MD 0.00 cm/week, 95% CI -0.01 to 0.02; trials = 5, participants = 549; very low certainty evidence). Only one trial reported neonatal mortality, with no deaths in either group (participants = 45). Moderate versus low protein concentration of human milk fortifier A moderate versus low protein concentration fortifier may increase weight gain (MD 2.08 g/kg/day, 95% CI 0.38 to 3.77; trials = 2, participants = 176; very low certainty evidence) with little to no effect on head circumference gain (MD 0.13 cm/week, 95% CI 0.00 to 0.26; I² = 85%; trials = 3, participants = 217; very low certainty evidence), but the evidence is very uncertain. There was low certainty evidence that a moderate protein concentration may increase length gain (MD 0.09 cm/week, 95% CI 0.05 to 0.14; trials = 3, participants = 217). Only one trial reported mortality and found no difference between groups (RR 0.48, 95% CI 0.05 to 5.17; participants = 112). No trials reported long term growth or neurodevelopmental outcomes including cerebral palsy and developmental delay., Authors' Conclusions: Feeding preterm infants with a human milk fortifier containing high amounts of protein (≥ 1.4g/100 mL EBM) compared with a fortifier containing moderate protein concentration (≥ 1 g to < 1.4 g/100 mL EBM) results in small increases in weight gain during the neonatal admission. There may also be small increases in weight and length gain when infants are fed a fortifier containing moderate versus low protein concentration (< 1 g protein/100 mL EBM). The certainty of this evidence is very low to moderate; therefore, results may change when the findings of ongoing studies are available. There is insufficient evidence to assess the impact of protein concentration on adverse effects or long term outcomes such as neurodevelopment. Further trials are needed to determine whether modest increases in weight gain observed with higher protein concentration fortifiers are associated with benefits or harms to long term growth and neurodevelopment., (Copyright © 2020 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.)

Aim: This study sought to establish research priorities in human milk banking and use of pasteurised donor human milk. It aimed to (i) collaborate with national stakeholders, including parents of preterm infants, human milk donors and health-care professionals, to identify evidence uncertainties and (ii) agree by consensus on a consolidated prioritised list of research questions., Methods: A consensus approach modelled on the James Lind Alliance was used. A steering group was formed, and key stakeholder organisations identified. Evidence uncertainties were gathered through an online survey and literature search. An iterative process was used to consolidate and rank questions. A final workshop was held to identify the top 10 research priorities., Results: A total of 391 evidence uncertainties were gathered from 202 respondents (38% parents of preterm infants/milk donors, 50% health-care professionals, 12% who identified as both a parent of preterm and health professional) and a further 15 were identified from literature. The steering group consolidated these to 39 evidence uncertainties, which were ranked via another survey. The top 24 questions were workshopped by 13 participants (four parents and nine clinicians) to determine the top 10 research priorities. These included the risks and benefits of using donor milk, optimum techniques for processing and the effects of these on the properties of milk, the nutrient profile of the milk and clinical criteria for prioritising receipt of milk., Conclusion: The top 10 research priorities in human milk banking and use of donor milk were identified and can be used to guide researchers., (© 2019 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Objective: Oxylipins are biologically active signaling molecules that initiate and resolve inflammation; they are synthesized by oxidation of polyunsaturated fatty acids (PUFAs) and reflect PUFA intake and status. The PUFA intake in preterm infants differs between countries because of the type of lipid emulsions used and the PUFA content of breast milk. We compared total blood PUFA, free PUFA and their oxylipin levels in dried whole blood samples from preterm infants born in Australia and Japan., Methods: We enrolled 30 and 14 preterm infants born less than 31 weeks' gestation, from Adelaide and Japan respectively. Blood samples were obtained from cord blood, and on postnatal days 4, 7, 14 and 28. Total PUFAs were measured using gas chromatography, while free fatty acids and oxylipins were screened using ultra high-performance liquid chromatography mass spectroscopy., Results: Differences in the levels of blood PUFA between the centres were found which were in line with the timing and type of lipid emulsion administration. Significant differences in longitudinal levels were seen more often in free PUFA and their oxylipins than in total blood PUFA. This was particularly true for AA and DHA. In contrast, differences in the levels could be seen in total blood EPA, as well as in free EPA and its oxylipins. Further, levels of many free PUFA and their oxylipins were higher in Japanese infants than in Australian infants., Conclusion: Differences in total and free fatty acids and unesterified oxylipins, were observed during the first weeks of life and between preterm infants born in Australia and Japan, which were likely a reflection of the type of lipid emulsion and timing of administration. The clinical significance of these changes remains to be explored., Competing Interests: Declaration of Competing Interest RAG served on the Fonterra Scientific Advisory Board (to September 2018), honorarium was paid to support travel and consulting time. In addition, RAG has a patent 'Stabilising and analysing Fatty Acids in a biological sample stored on solid media' licensed to Adelaide Research and Innovation, University of Adelaide. Other authors have no conflicts of interest to declare., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Growth patterns are known to differ between breastfed and formula-fed infants, but little is known about the relative impact of maternal smoking in pregnancy v. feeding mode on growth trajectory in infancy. We conducted a secondary analysis of a trial, the Tolerance of Infant Goat Milk Formula and Growth Assessment trial involving 290 healthy infants, to examine whether smoking in pregnancy modified the association between feeding mode and body composition of infants. Fat mass (FM) and fat-free mass (FFM) were estimated at 1, 2, 3, 4, 6 and 12 months of age using bioimpedance spectroscopy. Formula-fed infants (n 190) had a higher mean FFM at 4 months (mean difference (MD) 160 g, 95 % CI 50·4, 269·5 g, P < 0·05)) and 6 months (MD 179 g, 95 % CI 41·5, 316·9 g, P < 0·05) compared with the breastfed infants (n 100). Sub-group analysis of breastfed v. formula-fed infants by maternal smoking status in pregnancy showed that there were no differences in the FM and FFM between the breastfed and formula-fed infants whose mothers did not smoke in pregnancy. Formula-fed infants whose mothers smoked in pregnancy were smaller at birth and had a lower FM% and higher FFM% at 1 month compared with infants of non-smoking mothers regardless of feeding mode, but the differences were not significant at other time points. Adequately powered prospective studies with an appropriate design are warranted to better understand the relative impact of maternal smoking, feeding practice and the growth trajectory of infants.

The importance of omega-3 long chain polyunsaturated fatty acids in the perinatal period has been the focus of research for several decades. Infants born preterm miss out on the last trimester in utero transfer of omega-3 fatty acids and consequently have lower blood levels than infants born at term. Preterm infant formula was supplemented with the omega-3 docosahexaenoic acid and the omega-6 arachidonic acid from 2000 (to the level found in the breast milk of women consuming a western diet) based on trials reporting improvements in visual acuity. Docosahexaenoic acid supplementation beyond this level has not shown improvements in clinical or developmental outcomes, however the effect on childhood development in the most preterm infants remains to be resolved. Maternal omega-3 supplementation during pregnancy has the potential to reduce the incidence of preterm birth but may also, in some pregnancies, prolong gestation beyond term and increase fetal size., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Aim: This evidence-based review aims to answer the following structured clinical question: In preterm infants <37 weeks' gestation (patient), does early fortification of breast milk (intervention) compared to late fortification (control) improve growth outcomes at the time of discharge or affect length of hospital stay (outcome)?, Methods: MEDLINE, Embase, Maternity and Infant Care Database and Evidence-Based Medicine Reviews were searched for articles published from 2000 onwards that were relevant to the structured clinical question. The National Institute for Health and Care Excellence, National Health and Medical Research Council, Agency for Healthcare Research and Quality, National Institute of Health and Turning Research into Practice databases were also searched, and reference lists of relevant articles were reviewed., Results: A total of 167 articles, after removal of duplicates, were found and screened by title and abstract. Five full-text articles were ultimately included in the review., Conclusions: The results of this review suggest that early fortification is safe and well tolerated. However, earlier fortification has not been shown to have a significant impact on growth outcomes at time of discharge or length of stay. More research is required to determine if early fortification of breast milk may have benefits regarding longer-term growth and neurodevelopmental outcomes., (© 2019 Paediatrics and Child Health Division (The Royal Australasian College of Physicians).)

Long chain polyunsaturated fatty acid (LCPUFA) intake during infancy has been associated with many health benefits, and the LCPUFA intake of breastfed infants is largely dependent on the composition of breast milk. The conventional method for breast milk fatty acid profiling is complicated by the need for cold-chain transportation and storage, and the newly developed dried milk spot (DMS) technology overcomes these difficulties. This study aimed to determine the accuracy, sensitivity and applicability of the DMS method developed based on the PUFAcoat™ technology. Two hundred breast milk samples were analyzed using the conventional method and compared with the DMS method. In order to evaluate the usefulness of DMS for large scale international studies, we analyzed another 786 breast milk samples collected from mothers of preterm infants who participated in a large clinical trial conducted in Australia, New Zealand and Singapore. Fatty acids were measured using capillary gas chromatography and results were reported as weight percentage of total fatty acids. Strong correlations and tight variation were observed in total saturated, monounsaturated, n-6 and n-3 PUFAs between the conventional and DMS methods. The DMS method proved to be sensitive in differentiating the breast milk fatty acid profiles of women consuming different habitual diets as evidenced by the differences between the breast milk fatty acid composition between Australian and Singaporean population. This study demonstrates that the DMS and the conventional method provide interchangeable results, and the DMS method is a particularly useful tool for large-scale studies., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Protein intakes of preterm infants are frequently below recommendations, but few studies report accurate intakes due to the difficulty of analysing human milk clinically. This observational analysis from a randomised trial of infants born.

This systematic review and meta-analysis synthesised the post-1990 literature examining the effect of human milk on morbidity, specifically necrotising enterocolitis (NEC), late onset sepsis (LOS), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD) and neurodevelopment in infants born ≤28 weeks' gestation and/or publications with reported infant mean birth weight of ≤1500 g. Online databases including Medline, PubMed, CINAHL, Scopus, and the Cochrane Central Register of Controlled Trials were searched, and comparisons were grouped as follows: exclusive human milk (EHM) versus exclusive preterm formula (EPTF), any human milk (HM) versus EPTF, higher versus lower dose HM, and unpasteurised versus pasteurised HM. Experimental and observational studies were pooled separately in meta-analyses. Risk of bias was assessed for each individual study and the GRADE system used to judge the certainty of the findings. Forty-nine studies (with 56 reports) were included, of which 44 could be included in meta-analyses. HM provided a clear protective effect against NEC, with an approximate 4% reduction in incidence. HM also provided a possible reduction in LOS, severe ROP and severe NEC. Particularly for NEC, any volume of HM is better than EPTF, and the higher the dose the greater the protection. Evidence regarding pasteurisation is inconclusive, but it appears to have no effect on some outcomes. Improving the intake of mother's own milk (MOM) and/or donor HM results in small improvements in morbidity in this population.

The aim of this study was to assess the effect of feeding high protein human milk fortifier (HMF) on growth in preterm infants. In this single-centre randomised trial, 60 infants born 28⁻32 weeks' gestation were randomised to receive a higher protein HMF providing 1.8 g protein ( n = 31) or standard HMF providing 1 g protein per 100 mL expressed breast milk (EBM) ( n = 29). The primary outcome was rate of weight gain. Baseline characteristics were similar between groups. There was no difference between high and standard HMF groups for weight gain (mean difference (MD) -14 g/week; 95% CI -32, 4; p = 0.12), length gain (MD -0.01 cm/week; 95% CI -0.06, 0.03; p = 0.45) or head circumference gain (MD 0.007 cm/week; 95% CI -0.05, 0.06; p = 0.79), despite achieving a 0.7 g/kg/day increase in protein intake in the high protein group. Infants in the high protein group had a higher proportion of lean body mass at trial entry; however, there was no group by time effect on lean mass gains over the study. Increasing HMF protein content to 1.8 g per 100 mL EBM does not improve growth in preterm infants born 28⁻32 weeks' gestation.

Background: The effect of human milk intake on neurodevelopment in preterm infants is uncertain., Methods: We analyzed data from 611 participants in the DHA for Improvement of Neurodevelopmental Outcomes study, enrolled at ≤33 wk gestation from five Australian perinatal centers. The main exposures were (i) average daily human milk intake during the neonatal hospitalization and (ii) total duration of human milk intake before and after discharge. Outcomes were Bayley Scales of Infant Development, 2nd Edition Mental (MDI), and Psychomotor (PDI) Development Indexes., Results: Adjusting for confounders in linear regression, human milk intake was not associated with higher MDI (0.2 points per 25 ml/kg/d; 95% confidence interval (CI): -0.6, 1.0) or PDI (-0.3 points; 95% CI: -1.1, 0.4). Longer duration of human milk intake was also not associated with MDI (0.1 points per month; 95% CI: -0.2, 0.3) or PDI (-0.2 points per month; 95% CI: -0.5, 0.01) scores, except in infants born 29-33 wk gestation (n = 364, MDI 0.3 points higher per additional month, 95% CI: 0.1, 0.6)., Conclusions: We found no associations of human milk intake during the neonatal hospitalization with neurodevelopment at 18 mo corrected age.

Background: Preterm human milk-fed infants often experience suboptimal growth despite the use of human milk fortifier (HMF). The extra protein supplied in fortifiers may be inadequate to meet dietary protein requirements for preterm infants., Objective: We assessed the effect of human milk fortified with a higher-protein HMF on growth in preterm infants., Design: This is a randomized controlled trial in 92 preterm infants born at <31 wk gestation who received maternal breast milk that was fortified with HMF containing 1.4 g protein/100 mL (higher-protein group) or 1.0 g protein/100 mL (current practice) until discharge or estimated due date, whichever came first. The HMFs used were isocaloric and differed only in the amount of protein or carbohydrate. Length, weight, and head-circumference gains were assessed over the study duration., Results: Length gains did not differ between the higher- and standard-protein groups (mean difference: 0.06 cm/wk; 95% CI: -0.01, 0.12 cm/wk; P = 0.08). Infants in the higher-protein group achieved a greater weight at study end (mean difference: 220 g; 95% CI: 23, 419 g; P = 0.03). Secondary analyses showed a significant reduction in the proportion of infants who were less than the 10th percentile for length at the study end in the higher-protein group (risk difference: 0.186; 95% CI: 0.370, 0.003; P = 0.047)., Conclusions: A higher protein intake results in less growth faltering in human milk-fed preterm infants. It is possible that a higher-protein fortifier than used in this study is needed. This trial was registered with the Australian New Zealand Clinical Trials Registry (http://www.anzctr.org.au/) as ACTRN12606000525583.