PMID- 35601412
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220716
IS  - 2296-2360 (Print)
IS  - 2296-2360 (Electronic)
IS  - 2296-2360 (Linking)
VI  - 10
DP  - 2022
TI  - Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides: The First 
      Double-Blind, Randomized, Controlled Trial in Pre-term Infants.
PG  - 858380
LID - 10.3389/fped.2022.858380 [doi]
LID - 858380
AB  - There is growing evidence supporting the benefit of human milk oligosaccharides 
      (HMOs) on reducing risk of illnesses and improving immune function in newborn 
      infants, but evidence in pre-term infants is lacking. This randomized, 
      double-blind, placebo-controlled trial (NCT03607942) of pre-term infants 
      evaluated the effects of HMO supplementation on feeding tolerance, growth, and 
      safety in 7 neonatal units in France. Pre-term infants (27-33 weeks' gestation, 
      birth weight <1,700 g) were randomized early after birth to receive HMO 
      supplement (n = 43) [2'-fucosyllactose (2'FL) and lacto-N-neotetraose (LNnT) in a 
      10:1 ratio (0.374 g/kg body weight/day)] or an isocaloric placebo (n = 43) 
      consisting of only glucose (0.140 g/kg/day) until discharge from the neonatal 
      unit. Anthropometric z-scores were calculated using Fenton growth standards. 
      Primary outcome was feeding tolerance, measured by non-inferiority (NI) in days 
      to reach full enteral feeding (FEF) from birth in HMO vs. placebo group (NI 
      margin = 4+ days). Mean number of days on intervention prior to FEF was 8.9 and 
      10.3 days in HMO and placebo, respectively. Non-inferiority in time to reach FEF 
      in HMO (vs. placebo) was achieved [LS mean difference (95% CI) = -2.16 (-5.33, 
      1.00); upper bound of 95% CI < NI margin] in full analysis set and similar for 
      per protocol. Adjusted mean time to reach FEF from birth was 2 days shorter in 
      HMO (12.2) vs. placebo (14.3), although not statistically significant (p = 
      0.177). There was no difference in weight-for-age z-scores between groups 
      throughout the FEF period until discharge. Length-for-age z-scores were higher in 
      HMO at FEF day 14 [0.29 (0.02, 0.56), p = 0.037] and 21 [0.31 (0.02, 0.61), p = 
      0.037]. Head circumference-for-age z-score was higher in HMO vs. placebo at 
      discharge [0.42 (0.12, 0.71), p = 0.007]. Occurrence of adverse events (AEs) was 
      similar in both groups and relatively common in this population, whereas 2.3 and 
      14.3%, respectively, experienced investigator-confirmed, related AEs. HMO 
      supplementation is safe and well-tolerated in pre-term infants. After 9 days of 
      supplementation, the HMO group reached FEF 2 days earlier vs. placebo, although 
      the difference was not statistically significant. In addition, HMO 
      supplementation supports early postnatal growth, which may have a positive impact 
      on long-term growth and developmental outcomes.
CI  - Copyright (c) 2022 Hascoet, Chevallier, Gire, Brat, Roze, Norbert, Chen, Hartweg 
      and Billeaud.
FAU - Hascoet, Jean-Michel
AU  - Hascoet JM
AD  - Maternite Regionale Universitaire A. Pinard, Nancy, France.
FAU - Chevallier, Marie
AU  - Chevallier M
AD  - Hopital Couple Enfant, CHU de Grenoble Alpes, Grenoble, France.
FAU - Gire, Catherine
AU  - Gire C
AD  - Hopital Nord Chemin des Bourrely, Marseille, France.
FAU - Brat, Roselyne
AU  - Brat R
AD  - CHR Orleans, Orleans, France.
FAU - Roze, Jean-Christophe
AU  - Roze JC
AD  - Hopital Femme Enfant Adolescent Neonatologie et Reanimation Pediatrique, Nantes, 
      France.
FAU - Norbert, Karine
AU  - Norbert K
AD  - Centre Hospitalier de Pau, Pau, France.
FAU - Chen, Yipu
AU  - Chen Y
AD  - Nestle Product Technology Center-Nutrition, Vevey, Switzerland.
FAU - Hartweg, Mickael
AU  - Hartweg M
AD  - Nestle Clinical Development Unit, Lausanne, Switzerland.
FAU - Billeaud, Claude
AU  - Billeaud C
AD  - CHU de Bordeaux CIC, Hopital des Enfants, Bordeaux, France.
LA  - eng
PT  - Journal Article
DEP - 20220425
PL  - Switzerland
TA  - Front Pediatr
JT  - Frontiers in pediatrics
JID - 101615492
PMC - PMC9119431
OTO - NOTNLM
OT  - growth
OT  - human milk oligosaccharides (HMOs)
OT  - nutrition
OT  - pre-term
OT  - supplement
OT  - time to full enteral feeding
COIS- This study received funding from Societe des Produits Nestle S.A. The funder had 
      the following involvement with the study: interpretation of data, writing of this 
      article, and decision to submit it for publication. The authors declare that the 
      research was conducted in the absence of any commercial or financial 
      relationships that could be construed as a potential conflict of interest.
EDAT- 2022/05/24 06:00
MHDA- 2022/05/24 06:01
PMCR- 2022/04/25
CRDT- 2022/05/23 04:09
PHST- 2022/01/19 00:00 [received]
PHST- 2022/03/17 00:00 [accepted]
PHST- 2022/05/23 04:09 [entrez]
PHST- 2022/05/24 06:00 [pubmed]
PHST- 2022/05/24 06:01 [medline]
PHST- 2022/04/25 00:00 [pmc-release]
AID - 10.3389/fped.2022.858380 [doi]
PST - epublish
SO  - Front Pediatr. 2022 Apr 25;10:858380. doi: 10.3389/fped.2022.858380. eCollection 
      2022.