TY - JOUR
T1 - An Observational Cohort Study and Nested Randomized Controlled Trial on Nutrition and Growth Outcomes in Moderate and Late Preterm Infants (FLAMINGO)
AU - Kakaroukas, Andreas
AU - Abrahamse-Berkeveld, Marieke
AU - Berrington, Janet E.
AU - McNally, Richard J. Q.
AU - Stewart, Christopher J.
AU - Embleton, Nicholas D.
AU - van Elburg, Ruurd M.
N1 - Funding Information: This research was funded by Danone Nutricia Research via an Investigator Led Clinical Research Funding award. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication. Funding Information: Conflict of Interest: MA-B is an employee of Danone. RMvE was previously an employee of Danone. NDE declares research funding from Danone Early Life Nutrition and Prolacta Biosciences US, and lecture honoraria from Nestle Nutrition Institute. Publisher Copyright: © Copyright © 2021 Kakaroukas, Abrahamse-Berkeveld, Berrington, McNally, Stewart, Embleton and van Elburg. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/3/8
Y1 - 2021/3/8
N2 - 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.
AB - 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.
KW - body composition
KW - breastfeeding
KW - growth
KW - late preterm
KW - lipid
KW - moderate preterm
KW - nutrition
KW - prematurity
UR - http://www.scopus.com/inward/record.url?scp=85102924288&partnerID=8YFLogxK
U2 - https://doi.org/10.3389/fnut.2021.561419
DO - https://doi.org/10.3389/fnut.2021.561419
M3 - Article
C2 - 33763438
SN - 2296-861X
VL - 8
JO - Frontiers in Nutrition
JF - Frontiers in Nutrition
M1 - 561419
ER -