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.

Study Overview

• Status: Completed
• Conditions: Preterm Infant
• Intervention / Treatment: Other: Preterm infant formula

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Pilsen, Czechia, 304 60
    • University Hospital in Pilsen
• Poland
  • Cracovia, Poland, 30-663
    • Children's University Hospital
• Slovakia
  • Martin, Slovakia, 03659
    • University Hospital in Martin
  • Nové Zámky, Slovakia, 941 52
    • Fakultna nemocnica s poliklinikou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 days (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: single arm	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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Nestlé

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 10, 2018
• Primary Completion (ACTUAL): September 19, 2019
• Study Completion (ACTUAL): December 15, 2019

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (ACTUAL): November 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 24, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 17.14.INF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No