An interventional study of Preterm infant formula in Preterm Infant, sponsored by Société des Produits Nestlé (SPN). Completed at 4 sites in 3 countries. Open to participants aged Up to 5 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-25.
Sponsored by Société des Produits Nestlé (SPN) (part of Nestlé S.A.) · Not applicable, Interventional, and Other
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.
2,610 studies on the registry are indexed under Premature Birth; 507 are open to participants now.
This study's enrollment of 34 is below the median of 84 across 1,722 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →Société des Produits Nestlé (SPN) is the lead sponsor of 324 studies on the registry; 16 are open to participants now.
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Exclusion Criteria:
Other: Preterm infant formula
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.
Growth of preterm infants
Weight gain
Time frame: 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
Other growth parameter at other time points
Changes in weight gain (in g/day)
Time frame: 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.
Other growth parameter
Changes in length (cm)
Time frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Head circumference (HC) (cm)
Time frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.
Other growth parameter
Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed
Time frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD ..
Feeding intake:
Neonatal unit feeding questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
Time frame: daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth)
Feeding tolerance:
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).
Time frame: weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth)
Feeding intake:
Parent-reported questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
Time frame: Daily during 30 days after hospital discharge
Feeding tolerance:
Tolerance to feeding through parent-reported questionnaire. Questionnaire assessing stool consistency (watery, mushysoft, runny, formed, hard); stool frequency (range from 0-20 times a day); Bloody stool (yes or no).
Time frame: during the three days prior to the 30-day PD visit
Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin)
Clinical abnormal values will be captured as part of adverse event reporting.
Time frame: 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.
Number of AEs reported for safety assessment
through investigator-confirmed AE reporting
Time frame: 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.
Plan to share: No
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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