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Completed

NCT Number: NCT03728764

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

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

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Key information

Conditions

Preterm Infant Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 5 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital in Pilsen, Pilsen, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Preterm infant formula

Other

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 2, 2018
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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