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

N

Nestlé

Status

Completed

Conditions

Premature Infant

Treatments

Dietary Supplement: Placebo comparator
Dietary Supplement: HMO supplement

Study type

Interventional

Funder types

Industry

Identifiers

NCT03607942
17.02.INF

Details and patient eligibility

About

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.

Enrollment

86 patients

Sex

All

Ages

Under 7 days old

Volunteers

No Healthy Volunteers

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).

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

86 participants in 2 patient groups, including a placebo group

Experimental Formula
Experimental group
Description:
The experimental group will receive a liquid supplement containing 2 specific HMOs
Treatment:
Dietary Supplement: HMO supplement
Control Formula
Placebo Comparator group
Description:
The control group will receive a liquid placebo
Treatment:
Dietary Supplement: Placebo comparator

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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