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

Preterm Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03728764
• Other study ID #: 17.14.INF
• Status: Completed
• Phase: N/A
• Start date: October 10, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: February 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: December 15, 2019
• Est. primary completion date: September 19, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Preterm Infant

Intervention

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.

Locations

Country	Name	City	State
Czechia	University Hospital in Pilsen	Pilsen
Poland	Children's University Hospital	Cracovia
Slovakia	University Hospital in Martin	Martin
Slovakia	Fakultná nemocnica s poliklinikou	Nové Zámky

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Czechia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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 ..
Secondary	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)
Secondary	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)
Secondary	Feeding intake:	Parent-reported questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)	Daily during 30 days after hospital discharge
Secondary	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
Secondary	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.
Secondary	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.