Use of a Liquid Supplement Containing 2 Human Milk Oligosaccharides (HMOs) in Preterm Infants

NCT03607942 | Completed DMC

• 1 other identifier: 17.02.INF
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 7

Brief Summary

This is a prospective, randomized, double-blind, placebo-controlled trial in preterm infants conducted at least 4 centers in France, consisting of 2 parallel groups. The experimental group will receive a neonatal supplement containing 2 specific HMOs. The control group will receive a placebo neonatal supplement that does not contain any HMOs, but matched to the experimental product in energy content. This study will include a total of approximately 86 male and female preterm infants born between 27 and 32 weeks' gestational age with birth weight ≤1700 g, who are younger than 7 days of age. The primary objective of the study is to demonstrate the safety and tolerance of HMOs in preterm infants by monitoring weight gain rates in both of the two randomized groups.

Conditions

Premature Infant

Outcome Measures

Primary Outcomes (1)

• Feeding tolerance

  The primary objective is to demonstrate non-inferiority in feeding tolerance (defined as number of days to reach full enteral feeding) of preterm infants receiving a liquid supplement composed of 2 HMOs compared to those receiving the placebo.

  Change from Full Enteral Feeding (FEF) Day 1 (start of FEF defined as achieving 150ml/day/kg of enteral feeding and discontinuation of parenteral feeding) and FEF Day 21 (approximately 5 weeks after enrollment)

Secondary Outcomes (13)

• Length

  Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

• Head circumference

  Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

• Weight gain

  Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

• Assessment of infant illnesses and infections

  Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

• Tolerance to feeding regimen

  Change from enrolment (baseline) (if feasible) through study completion, average of 4 months

Study Arms (2)

Experimental Formula

EXPERIMENTAL

The experimental group will receive a liquid supplement containing 2 specific HMOs

Dietary Supplement: HMO supplement

Control Formula

PLACEBO COMPARATOR

The control group will receive a liquid placebo

Dietary Supplement: Placebo comparator

Interventions

HMO supplement DIETARY_SUPPLEMENT

HMO supplement will be given three times a day, not mixed with any feeding.

Experimental Formula

Placebo comparator DIETARY_SUPPLEMENT

Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.

Control Formula

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infant's birth weight ≤1700 g.
• Infant's gestational age ≥ 27 weeks + 0 days and ≤ 32 weeks + 6 days.
• Infant is clinically stable
• Infants are eligible to start HMOs / placebo as soon as possible after birth, but still within the first 7 days of life.
• Written informed consent has been obtained from the parents/legally acceptable representative (LAR).

You may not qualify if:

• Parents not willing / not able to comply with the requirements of study protocol.
• Infants receiving ongoing prophylactic antifungal therapies.
• Infants experiencing early onset sepsis.
• Major congenital or chromosomal abnormality known to affect growth.
• Liver failure.
• Severe intrauterine growth restriction (IUGR) as defined by having birth weight less than 2nd percentile on the Fenton growth chart.
• Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification) .
• Infant in critical condition needing intubation or inotropic agents for treatment.
• Infant requiring prolonged (more than 3 doses) of steroid treatment.
• Infants' participation in another interventional clinical trial that would have significant impact on current study's results.
• Infants who have already achieved Full Enteral Feeding (FEF) prior to enrolment, using the definition accepted by neonatal unit as per standard practice (150 mL/kg/day).

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (7)

CHU de Bordeaux - Hôpital des Enfants

Bordeaux, 33000, France

Location

Hôpital Couple Enfant

Grenoble, 38043, France

Location

Hôpital Nord

Marseille, 13000, France

Location

Maternité Régionale Universitaire A. Pinard - CHRU Nancy

Nancy, 54035, France

Location

Hôpital femme-maternité

Nantes, 44093, France

Location

CHR Orléans - Hôpital de la Source

Orléans, 45100, France

Location

Centre Hospitalier de Pau

Pau, 64046, France

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Jean-Michel Hascoët, Prof

  CHRU Nancy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: July 31, 2018
• Study Start: August 6, 2018
• Primary Completion: October 30, 2020
• Study Completion: November 30, 2022
• Last Updated: March 21, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (7)