Clinical trial NCT03728764: Growth and Safety of a Two-stage Feeding System in Preterm Infants
Official title: Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2018-11-02
Enrollment: 34
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Growth of preterm infants
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
Secondary outcomes:
measure: Other growth parameter at other time points
timeFrame: from Pre-FEF Day 1 to FEF Day 1, and then weekly from FEF Day 1 until hospital discharge (on average 7 weeks after birth) and at 30-days PD.
measure: Other growth parameter
timeFrame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
measure: Other growth parameter
timeFrame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
measure: Other growth parameter
timeFrame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD ..
measure: Feeding intake:
timeFrame: daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth)
measure: Feeding tolerance:
timeFrame: weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
measure: Feeding intake:
timeFrame: Daily during 30 days after hospital discharge
measure: Feeding tolerance:
timeFrame: during the three days prior to the 30-day PD visit
measure: Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin)
timeFrame: will be obtained at Enrolment (baseline), if possible, Pre-FEF Day 1, FEF Day1, thereafter weekly until hospital discharge (on average 7 weeks after birth)., and lastly at 30 days post-discharge.
measure: Number of AEs reported for safety assessment
timeFrame: from the time the mother has consented to the infant's participation in the study soon after birth but no later than 5 days of age after birth until the 30 days PD visit in the clinic.
Other outcomes:
Locations:
city: Pilsen
country: Czechia
facility: University Hospital in Pilsen
city: Cracovia
country: Poland
facility: Children's University Hospital
city: Martin
country: Slovakia
facility: University Hospital in Martin
city: Nové Zámky
country: Slovakia
facility: Fakultná nemocnica s poliklinikou
Study officials:
References: