Prebiotic in Preterm Infants



Status:Recruiting
Conditions:Food Studies, Women's Studies
Therapuetic Areas:Pharmacology / Toxicology, Reproductive
Healthy:No
Age Range:Any
Updated:7/20/2018
Start Date:July 4, 2018
End Date:June 1, 2020

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The Impact of Prebiotic on Growth, Feeding Progression and Neurodevelopment in Preterm Infants

This is a double blinded, randomized, controlled trial of prebiotic in infants born between
29 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 >1000 gram to <1500 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.


Inclusion Criteria:

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

1. Subjects will be preterm infants born 1001 and 1500 g birthweight (inclusive),
and >29 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
We found this trial at
1
site
700 Children's Drive
Columbus, Ohio 43206
Phone: 614-722-3481
?
mi
from
Columbus, OH
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