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

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

Detailed Description
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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.

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

Conditions
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Preterm Infant

Intervention / Treatment
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* Other: Preterm infant formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent has been obtained from the parents/legally acceptable representative (LAR). 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. Infant's gestational age ≥ 27 weeks and ≤ 32 weeks. Infant is clinically stable. Infants are eligible to start experimental formula within the first 5 days (≤120 hours) of life. Exclusion Criteria: Parents not willing / not able to comply with the requirements of study protocol. Infants experiencing early onset sepsis. Major congenital or chromosomal abnormality known to affect growth. Preterm infants experiencing liver failure. Peri-/intra-ventricular haemorrhage. Infant requiring prolonged (more than 3 doses) of steroid treatment. Infants' participation in another interventional clinical trial.

Ages Eligible for Study
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Maximum Age: 5 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm<br> | Other: Preterm infant formula<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth of preterm infants | Weight gain | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other growth parameter at other time points | Changes in weight gain (in g/day) | 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) | 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) | 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 | 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) | 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). | 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) | 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). | 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. | 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 | 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. |