CompletedNot Applicable

Growth and Safety of Two Partially-hydrolyzed Feeding Systems for Preterm Infants

Germany, Poland, Slovakia28 participantsStarted 2020-09-10

Plain-language summary

This is an open-label trial consisting of two sub-studies to be conducted sequentially with the purpose of evaluating the safety and suitability of a two feeding systems in pre-term infants (one containing HMOs and one without HMOs).

Who can participate

Age range10 Days

SexALL

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Inclusion criteria

✓. Written informed consent has been obtained from one or both parent(s) /legally acceptable representative (LAR) in accordance with local regulation.
✓. Infants' birth weight ≤1500 g and AGA.
✓. Infant's gestational age \< 37 weeks.
✓. Infant is clinically stable and does not have deteriorating respiratory function after birth.
✓. Infant is eligible to start experimental formula after 24 hours of trophic feeding, but still within the first 10 days (≤240 hours) of life.

Exclusion criteria

✕. Parent(s) not willing / not able to comply with the requirements of study protocol.
✕. Infant is experiencing early onset sepsis.
✕. Major congenital or chromosomal abnormality known to affect growth.
✕. Liver failure.
✕. Peri-/intra-ventricular haemorrhage (grade 3-4 in Papille classification).
✕. Infant who has siblings with diagnosed allergies or intolerances to lactose or cow's milk.
✕. Infant's participation in another interventional clinical trial.
✕. Infant has already achieved FEF prior to enrolment, using the definition accepted by Neonatal Unit as per standard practice (150 mL/kg/day).

What they're measuring

Growth

Timeframe: From FEF Day 1 to when infant reaches 1800 g (on average between 4 to 6 weeks after birth) or hospital discharge (on average 7 weeks after birth), whichever comes earlier

Trial details

NCT IDNCT04639518

SponsorSociété des Produits Nestlé (SPN)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-06-30

View on ClinicalTrials.gov More Pre-term Infant trials