Formula with large, milk phospholipid-coated lipid droplets in late-moderate preterm infants: a double-blind RCT.

BACKGROUND: Limited evidence exists on the preferred feeding method when breastfeeding is not possible in late and moderate preterm (LMPT) infants. This RCT evaluates growth, safety, and tolerance of a concept infant formula (IF) with large, milk phospholipid-coated lipid droplets enriched in dairy lipids in LMPT infants with primary objective to demonstrate non-inferiority of daily weight gain from randomization to 3 months corrected age compared to a standard IF. METHODS: LMPT infants were randomized before or around term equivalent age to either the concept (n = 21) or standard IF (n = 20). Forty-one breastfed (BF) infants served as reference. RESULTS: Due to unintended low recruitment, non-inferiority in daily weight gain could not be demonstrated for the Concept compared to the Control group, but was compared to the BF group. Other outcomes were similar between the formula groups, except for an apparent larger head circumference gain in the Concept group. No apparent differences in growth and body composition outcomes were observed between the Concept and BF reference groups. CONCLUSION: This small-scale study suggests the concept IF is a safe alternative for parents who choose IF to feed their LMPT infant. Larger trials are needed to better determine impacts on head growth or body composition. IMPACT: In a small group of late and moderate preterm infants, growth from randomization until 3 months corrected age of infants fed with a concept infant formula with large, milk phospholipid-coated lipid droplets was not -significantly different from infants fed a standard infant formula. Infants in the Concept group had non-significant larger gain in head circumference compared to the Control group; larger trials are needed to confirm this finding. Both formulas were well-tolerated, with no differences in adverse events. The concept formula is potentially a safe alternative for parents of moderate to late preterm infants who choose to use formula milk.

Early infancy growth, body composition and type of feeding in late and moderate preterms.

BACKGROUND: Late and moderate preterm (LMPT) infants are at risk for adverse later life outcomes. We determined the association between feeding method at enrolment and growth and body composition of LMPT infants until 3 months corrected age (3mCA). METHODS: Infants born between 32+0 and 36+6 weeks of gestation (n = 107) were enrolled up to 4 weeks corrected age and stratified according to feeding at enrolment. We performed anthropometric measurements at enrolment, term equivalent age (TEA) and 3mCA, including skinfold measurements and body composition using dual X-ray absorptiometry (DEXA). RESULTS: Feeding method at enrolment was associated with fat mass (FM) (breast 554.9 g, mixed 716.8 g, formula 637.7 g, p = 0.048), lean body mass (LM) (2512 g, 2853 g, 2722 g, respectively, p = 0.009) and lean mass index (LMI) (10.6 kg/m2, 11.6 kg/m2,11.2 kg/m2 respectively, p = 0.008) at TEA, but not 3mCA. Breastfed infants demonstrated greater increase in LM (breast 1707 g, mixed 1536 g, formula 1384 g, p = 0.03) and LMI (1.23 kg/m2, 0.10 kg/m2, 0.52 kg/m2, respectively, p = 0.022) between TEA and 3mCA. CONCLUSIONS: Breastfed LMPT infants have lower FM and greater LM increase and LMI increase up to 3mCA compared to formula or mixed-fed infants. These findings stress the importance of supporting breastfeeding in this population. IMPACT: Infants born late and moderate preterm age who are exclusively breastfed soon after birth gain more lean mass up to 3 months corrected age compared to mixed- or formula-fed infants. Breastfed infants have lower lean and fat mass at term equivalent age compared to mixed- and formula-fed infants. This is the first study exploring this population's growth and body composition in detail at 3 months corrected age. Our results underline the importance of supporting mothers to initiate and continue breastfeeding at least until 3 months corrected age.

Barriers and Facilitators to Breastfeeding in Moderate and Late Preterm Infants: A Systematic Review.

Rationale: Most of the preterm infants are born between 32 and 36 weeks of gestation (moderate to late preterm infants [MLPIs]). This comes with significant short- and long-term risks. Breastfeeding reduces many of these risks, but breastfeeding rates in MLPIs are lower than those in full-term infants. We performed a systematic review of studies identifying factors associated with successful breastfeeding in MLPIs and interventions to improve breastfeeding. Methods: Systematic search performed using PubMed April 24, 2020. In total, 11 articles describing barriers to breastfeeding in MLPIs and 6 articles about interventions to improve breastfeeding were included. Interventions were categorized according to different outcomes: breastfeeding initiation, continuation for 5 days to 6 weeks, and continuation ≥3 months. Because of heterogeneity in study characteristics, no meta-analysis was performed. Results: Breastfeeding rates were lower in those with lower socioeconomic status and single-parent households. Providing parents with more information and direct health care support significantly improved breastfeeding initiation. Cup feeding instead of bottle feeding had inconsistent effects on breastfeeding initiation and continuation. Continuous skin-to-skin contact did not affect breastfeeding initiation or continuation. Discussion: Risk groups for lower breastfeeding rates of MLPIs include mothers with lower socioeconomic status and single mothers. Interventions that may improve breastfeeding include cup feeding and providing parents with more information and health care support. Key limitations of included studies are lack of adequate adjustment for confounders and lack of blinding. However, this is the first systematic review identifying both risk groups and interventions to improve breastfeeding in MLPIs.

An Observational Cohort Study and Nested Randomized Controlled Trial on Nutrition and Growth Outcomes in Moderate and Late Preterm Infants (FLAMINGO).

Background: Over the past decades, the preterm birth rate has increased, mostly due to a rise in late and moderate preterm (LMPT, 32-36 weeks gestation) births. LMPT birth affects 6-7% of all births in the United Kingdom and is associated with increased morbidity risk after birth in infancy as well as in adulthood. Early life nutrition has a critical role in determining infant growth and development, but there are limited data specifically addressing LMPT infants, which was the rationale for the design of the current study. Objective: The Feeding Late and Moderate Infants and Growth Outcomes (FLAMINGO) study aims to improve understanding of the longitudinal growth, nutritional needs, and body composition of LMPT infants as well as their microbiome development and neurodevelopment. In addition, having a nested non-inferiority trial enables evaluation of the nutritional adequacy of a concept IMF with large milk phospholipid-coated lipid droplets comprising dairy and vegetable lipids. The primary outcome of this RCT is daily weight gain until 3 months corrected age. Methods: A total of 250 healthy LMPT infants (32+0-36+6 weeks gestational age) with birth weight 1.25-3.0 kg will be recruited to the cohort, of which 140 infants are anticipated to be enrolled in the RCT. During six visits over the first 2 years of life, anthropometry, body composition (using dual energy X-Ray absorptiometry), feeding behavior, and developmental outcomes will be measured. Saliva and stool samples will be collected for oral and gut microbiota assessment. Discussion: The FLAMINGO study will improve understanding of the longitudinal growth, body composition development, and feeding characteristics of LMPT infants and gain insights into their microbiome and neurodevelopment. Study Registration: www.isrctn.com; Identifier ISRCTN15469594.