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

Primary Purpose

Preterm Infant

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Preterm infant formula
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Infant

Eligibility Criteria

undefined - 5 Days (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University Hospital in Pilsen
  • Children's University Hospital
  • University Hospital in Martin
  • Fakultná nemocnica s poliklinikou

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

single arm

Arm Description

Outcomes

Primary Outcome Measures

Growth of preterm infants
Weight gain

Secondary Outcome Measures

Other growth parameter at other time points
Changes in weight gain (in g/day)
Other growth parameter
Changes in length (cm)
Other growth parameter
Head circumference (HC) (cm)
Other growth parameter
Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed
Feeding intake:
Neonatal unit feeding questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
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).
Feeding intake:
Parent-reported questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
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).
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.
Number of AEs reported for safety assessment
through investigator-confirmed AE reporting

Full Information

First Posted
August 2, 2018
Last Updated
February 24, 2020
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT03728764
Brief Title
Growth and Safety of a Two-stage Feeding System in Preterm Infants
Official Title
Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2018 (Actual)
Primary Completion Date
September 19, 2019 (Actual)
Study Completion Date
December 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Preterm infant formula
Intervention Description
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.
Primary Outcome Measure Information:
Title
Growth of preterm infants
Description
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
Secondary Outcome Measure Information:
Title
Other growth parameter at other time points
Description
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.
Title
Other growth parameter
Description
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.
Title
Other growth parameter
Description
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.
Title
Other growth parameter
Description
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 ..
Title
Feeding intake:
Description
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)
Title
Feeding tolerance:
Description
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)
Title
Feeding intake:
Description
Parent-reported questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
Time Frame
Daily during 30 days after hospital discharge
Title
Feeding tolerance:
Description
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
Title
Neonatal unit routine blood collection for safety assessment (serum blood levels of blood urea nitrogen (BUN), creatinine, albumin, pre albumin)
Description
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.
Title
Number of AEs reported for safety assessment
Description
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.

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University Hospital in Pilsen
City
Pilsen
ZIP/Postal Code
304 60
Country
Czechia
Facility Name
Children's University Hospital
City
Cracovia
ZIP/Postal Code
30-663
Country
Poland
Facility Name
University Hospital in Martin
City
Martin
ZIP/Postal Code
03659
Country
Slovakia
Facility Name
Fakultná nemocnica s poliklinikou
City
Nové Zámky
ZIP/Postal Code
941 52
Country
Slovakia

12. IPD Sharing Statement

Plan to Share IPD
No

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

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