Preterm Infant
Conditions
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.
Interventions
Preterm infants will receive Stage 1 investigative product as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive stage 2 preterm formula from when 1.8 kg of body weight is achieved until 1 month after hospital discharge.
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Days
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth of preterm infants | 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 | Weight gain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other growth parameter | from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD. | Changes in length (cm) |
| Feeding intake: | daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth) | Neonatal unit feeding questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml) |
| Other growth parameter at other time points | 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. | Changes in weight gain (in g/day) |
| Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin) | 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. | Clinical abnormal values will be captured as part of adverse event reporting. |
| Number of AEs reported for safety assessment | 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. | through investigator-confirmed AE reporting |
| Feeding tolerance: | weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth) | Tolerance to feeding regimen through neonatal unit questionnaire. Questionnaire assessing stool consistency (watery, mushysoft, runny, formed, hard); stool frequency (range from 0-20 times a day); Bloody stool (yes or no). |
Countries
Czechia, Poland, Slovakia
Outcome results
None listed