Growth and Safety of a Two-stage Feeding System in Preterm Infants

Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study

This study evaluates the safety and suitability of the two-stage feeding system in preterm infants.

This open-label trial will be conducted in up to 74 preterm infants to evaluate the formula as it would typically be used in the neonatal care unit and to document the safety and suitability of the two-stage feeding system in terms of growth in comparison to recommended growth goals, feeding tolerance, biochemical parameters, and adverse event reporting.

Inclusion Criteria:

1. Written informed consent has been obtained from the parents/legally acceptable representative (LAR).
2. Infant's birth weight ≤1500 g and appropriate for gestational age (AGA) as defined by weight ≥10 percentile and ≤90 percentile on the Fenton growth chart.
3. Infant's gestational age ≥ 27 weeks and ≤ 32 weeks.
4. Infant is clinically stable.
5. Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life.

Exclusion Criteria:

1. Parents not willing / not able to comply with the requirements of study protocol.
2. Infants experiencing early onset sepsis.
3. Major congenital or chromosomal abnormality known to affect growth.
4. Preterm infants experiencing liver failure.
5. Peri-/intra-ventricular haemorrhage.
6. Infant requiring prolonged (more than 3 doses) of steroid treatment.
7. Infants' participation in another interventional clinical trial.