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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 : Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Nestlé

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

Condition or disease Intervention/treatment Phase
Preterm Infant Other: Preterm infant formula Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Growth and Safety of a Two-stage Feeding System in Preterm Infants: a Prospective, Non-randomized, Open-label, Single-arm Study
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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)

  6. 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).

  7. 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)

  8. 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).

  9. 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.

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03728764


Contacts
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Contact: Cécile NICOLAS DENIZOU 0041 21 785 8606 ext 8606 cecile.nicolasdenizou@rd.nestle.com
Contact: Przemko Kwinta +48 812) 658 44 46 klinchdz@cm-uj.krakow.pl

Locations
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Czechia
University Hospital in Pilsen Not yet recruiting
Pilsen, Czechia, 304 60
Contact: Jiri Dort, MD, PhD    +420 377 105 498    dortj@fnplzen.cz   
Principal Investigator: Jiri Dort, MD, PhD         
Poland
Children's University Hospital Not yet recruiting
Cracovia, Poland, 30-663
Contact: Przemko Kwinta, MD, PhD    +48 (12) 658 0256    klinchdz@cm-uj.krakow.pl   
Principal Investigator: Przemko Kwinta         
Slovakia
University Hospital in Martin Recruiting
Martin, Slovakia, 03659
Contact: Mirko Zibolen, MD    +421 43 4203 759    zibolen@jfmed.uniba.sk   
Principal Investigator: Mirko Zibolen, MD         
Fakultná nemocnica s poliklinikou Not yet recruiting
Nové Zámky, Slovakia, 941 52
Contact: Klaudia Demova    +421 356 91 2202    klaudia.demova@nspnz.sk   
Principal Investigator: Klaudia Demova, MD         
Sponsors and Collaborators
Nestlé

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Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT03728764     History of Changes
Other Study ID Numbers: 17.14.INF
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications