NCT03728764

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

November 2, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

February 25, 2020

Status Verified

February 1, 2020

Enrollment Period

11 months

First QC Date

August 2, 2018

Last Update Submit

February 24, 2020

Conditions

Preterm Infant

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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.

  • Other growth parameter

    from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.

  • Other growth parameter

    from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD.

  • Other growth parameter

    from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD ..

  • Feeding intake:

    daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth)

  • +5 more secondary outcomes

Study Arms (1)

single arm

OTHER
Other: Preterm infant formula

Interventions

Preterm infant formulaOTHER

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.

single arm

Eligibility Criteria

AgeUp to 5 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital in Pilsen

Pilsen, 304 60, Czechia

Location

Children's University Hospital

Krakow, 30-663, Poland

Location

University Hospital in Martin

Martin, 03659, Slovakia

Location

Fakultná nemocnica s poliklinikou

Nové Zámky, 941 52, Slovakia

Location

Related Publications (1)

  • Kwinta P, Lazarova S, Demova K, Chen Y, Hartweg M, Krattinger LF, Fumero C, Buczynska A, Durlak W, Uhrikova Z, Kozar M, Samuel TM, Zibolen M. Effects of two-stage preterm formulas on growth, nutritional biomarkers, and neurodevelopment in preterm infants. Front Pediatr. 2024 Nov 22;12:1427050. doi: 10.3389/fped.2024.1427050. eCollection 2024.

    PMID: 39649400DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2018

First Posted

November 2, 2018

Study Start

October 10, 2018

Primary Completion

September 19, 2019

Study Completion

December 15, 2019

Last Updated

February 25, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

SL(2)CZ(1)PL(1)