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An Observational Cohort Study and Nested Randomized Controlled Trial on Nutrition and Growth Outcomes in Moderate and
Andreas Kakaroukas1, Marieke Abrahamse-Berkeveld2, Janet E Berrington1,3
1Newcastle Neonatal Service, Royal Victoria Infirmary, Newcastle upon Tyne Hospitals National Health Service (NHS) Foundation Trust, Newcastle upon Tyne, United Kingdom.
Insights
The FLAMINGO study investigates the growth and development of late and moderate preterm (LMPT) infants. It aims to enhance understanding of their nutritional needs and microbiome development for improved infant health outcomes.
Area of Science:
- Neonatal nutrition and development
- Infant growth and body composition
- Microbiome research
Background:
- Increasing rates of late and moderate preterm (LMPT) births (32-36 weeks gestation) are linked to higher infant morbidity.
- Early nutrition is crucial for infant development, yet data for LMPT infants are scarce.
- The FLAMINGO study addresses this gap by focusing on LMPT infant growth and development.
Purpose of the Study:
- To understand longitudinal growth, nutritional requirements, and body composition in LMPT infants.
- To investigate microbiome development and neurodevelopment in this population.
- To evaluate a novel infant formula's nutritional adequacy through a nested randomized controlled trial (RCT).
Main Methods:
- Recruitment of 250 healthy LMPT infants (32+0-36+6 weeks gestation).
- A nested RCT will enroll 140 infants to assess a novel infant formula.
- Data collection includes anthropometry, body composition (DXA), feeding, development, and microbiome samples over two years.
Main Results:
- Primary outcome of the RCT: daily weight gain until 3 months corrected age.
- Longitudinal data on growth, body composition, and neurodevelopment will be collected.
- Oral and gut microbiota will be assessed through saliva and stool samples.
Conclusions:
- The FLAMINGO study will provide critical insights into the growth, body composition, and feeding of LMPT infants.
- Findings will enhance understanding of LMPT infant microbiome and neurodevelopment.
- Results may inform improved nutritional strategies for preterm infants.
Abstract:
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.
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