Clinical trial NCT03306316: Prebiotic in Preterm Infants
Official title: The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infant
Development, Infant
Nutrition
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2017-10-11
Enrollment: 44
Sex: ALL
Minimum age (years): 7
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a double blinded, randomized, controlled trial of prebiotic in infants born between 26 and 32 weeks gestational age. The investigators anticipate enrollment of 90 subjects in total and for the study to be completed in 18 months. The investigators anticipate collecting clinical data, anthropometrics, stool samples (requiring appropriate storage through analysis), salivary samples from mother and infant, discarded blood samples from baby after the standard care lab tests are done, a single, optional blood draw at the conclusion of the study, and subjecting infants to a neurodevelopmental survey at study completion.

The overall goal of this study is to test prebiotic administration to human milk-fed infants who are 700 gram to 1800 gram birthweight. The goal of this study will be addressed through one primary aim, a secondary aim, and exploratory aims, indicated below:

Primary aim: Compare weight, length, and head circumference Z-score growth between the study and placebo groups.

Secondary aim: Compare the time taken to achieve full feedings (135 mL/kg/day or more) between the study and placebo groups.

Exploratory aim 1: Compare neurobehavior, as measured by the validated Neonatal intensive care unit Network Neurobehavioral Scale (NNNS), between the study and placebo groups.

Exploratory aim 2: Compare fecal calprotectin levels to determine the impact of supplementation on reducing intestinal inflammation between the study and placebo groups.

Exploratory aim 3: Compare fecal microbiome between the prebiotic and placebo groups, to determine whether there is a shift in microbial composition towards bifidobacteria and other microbes that are capable of metabolizing prebiotic.


Eligibility criteria: Inclusion Criteria:

* Preterm infants who meet the following inclusion criteria will be eligible for randomization:

  1. Subjects will be preterm infants born 700 and 1800 g birthweight (inclusive), and \>/=26 weeks to 31 6/7 weeks.
  2. Subject's parent(s) or legal guardian(s) have voluntarily signed and dated an informed consent form (ICF). They have also provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
  3. Signed consent is obtained by day 10 after birth.
  4. Mother plans to provide her own milk or consents to use of donor human milk in NICU.

Exclusion Criteria:

* Infants with the following conditions or situations at the time of randomization will be excluded from the study:

  1. Subject has known congenital anomalies.
  2. Administration of enteral clinical product must be initiated by 9 ± 2 days of life (birth date is day of life 0).
  3. Confirmed necrotizing enterocolitis (Bell's Stage II or III, Appendix J) or confirmed sepsis (positive culture requiring antibiotic treatment).
  4. Steroid use at time of randomization
  5. Mechanical ventilator dependence.
  6. \>2 days of antimicrobial use prior to enrollment
  7. Maternal incapacity: including maternal opioids, cocaine or alcohol abuse during pregnancy or current
  8. Mother or infant is currently receiving treatment consistent with HIV therapy.
  9. Mother plans to formula feed exclusively and has not consented to use of donor milk during NICU stay.
  10. Infant with intraventricular hemorrhage

Primary outcomes:
measure: Weight
timeFrame: Enrollment through study day 45
measure: Length
timeFrame: Enrollment through study day 45
measure: Head Circumference
timeFrame: Enrollment through study day 45
Secondary outcomes:
measure: Adaptation
timeFrame: Enrollment through study day 45
Other outcomes:
measure: Neurobehavior
timeFrame: Enrollment through study day 45
measure: Gut inflammation
timeFrame: Enrollment through study day 45
measure: Fecal microbiome
timeFrame: Enrollment through study day 45
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital and affiliated NICUs
state: Ohio
Study officials:
References: