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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-06

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Premature Infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Formula

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

Group Type EXPERIMENTAL

HMO supplement

Intervention Type DIETARY_SUPPLEMENT

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

Control Formula

The control group will receive a liquid placebo

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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HMO supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo comparator

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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).

Exclusion Criteria

* 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).

Maximum Eligible Age

7 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No