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

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ClinicalTrials.gov Identifier: NCT03728764
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE August 2, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date February 25, 2020
Actual Study Start Date  ICMJE October 10, 2018
Actual Primary Completion Date September 19, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Growth of preterm infants [ 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 ]
Weight gain
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
  • Other growth parameter at other time points [ 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. ]
    Changes in weight gain (in g/day)
  • Other growth parameter [ Time Frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD. ]
    Changes in length (cm)
  • Other growth parameter [ Time Frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD. ]
    Head circumference (HC) (cm)
  • Other growth parameter [ Time Frame: from Pre-FEF Day 1 to hospital discharge (on average 7 weeks after birth) and at 30-days PD .. ]
    Corresponding z-scores and changes in z-scores expressed using Fenton growth chart will be analyzed
  • Feeding intake: [ Time Frame: daily between Pre-FEF day 1 and hospital discharge (on average 7 weeks after birth) ]
    Neonatal unit feeding questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
  • Feeding tolerance: [ Time Frame: weekly between FEF Day 1 and hospital discharge (on average 7 weeks after birth) ]
    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: [ Time Frame: Daily during 30 days after hospital discharge ]
    Parent-reported questionnaire capturing milk intake (Volume in ml/range from 0 to 1000ml)
  • Feeding tolerance: [ Time Frame: during the three days prior to the 30-day PD visit ]
    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) [ 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. ]
    Clinical abnormal values will be captured as part of adverse event reporting.
  • Number of AEs reported for safety assessment [ 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. ]
    through investigator-confirmed AE reporting
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Growth and Safety of a Two-stage Feeding System in Preterm Infants
Official Title  ICMJE Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Preterm Infant
Intervention  ICMJE 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.
Study Arms  ICMJE single arm
Intervention: Other: Preterm infant formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 24, 2020)
34
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2018)
74
Actual Study Completion Date  ICMJE December 15, 2019
Actual Primary Completion Date September 19, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 5 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Czechia,   Poland,   Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03728764
Other Study ID Numbers  ICMJE 17.14.INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nestlé
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP