NCT02353013

Brief Summary

The investigators will compare weight gain based on fat accretion and change in body composition in preterm infants receiving different amounts of enteral protein.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

December 22, 2017

Status Verified

December 1, 2017

Enrollment Period

2.6 years

First QC Date

January 28, 2015

Last Update Submit

December 20, 2017

Conditions

Premature; Infant, Light-for-dates

Keywords

protein intakebody composition

Outcome Measures

Primary Outcomes (1)

  • Weight gain due to fat mass

    4 weeks

Secondary Outcomes (4)

  • Change in body weight

    4 weeks

  • Change in percent fat mass

    4 weeks

  • Change in length

    4 weeks

  • Change in head circumference

    4 weeks

Study Arms (2)

Standard Protein Group

ACTIVE COMPARATOR

For infants in this group, the target protein-energy ratio (PER) will be \~3 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula.

Dietary Supplement: Standard fortification

Enhanced Protein Group

EXPERIMENTAL

For infants in this group, the target protein-energy ratio (PER) will be \~4 g/100 kcal. This will be achieved by providing standard fortification by adding a commercially available human milk fortifier to human milk or by providing a preterm formula. In addition, liquid protein will be added to provide protein supplementation and increase the PER.

Dietary Supplement: Protein supplementationDietary Supplement: Standard fortification

Interventions

Protein supplementationDIETARY_SUPPLEMENT

Standard fortification of human milk may not have enough protein for optimal growth of premature infants. The investigators will add extra protein to this group to increase the protein consumed.

Enhanced Protein Group
Standard fortificationDIETARY_SUPPLEMENT

Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.

Enhanced Protein GroupStandard Protein Group

Eligibility Criteria

Age1 Minute - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature infants born less than 32 weeks EGA
  • Growth that is appropriate for gestational age (AGA)
  • Admitted to OU Children's NICU, inborn or outborn
  • Receiving enteral feedings \<100 mL/kg/day
  • Hemodynamically stable

You may not qualify if:

  • Severe congenital anomalies to include congenital heart disease, chromosomal anomalies, open neural tube defects, and/or intestinal anomalies precluding enteral feedings
  • Growth restriction, growth that is small for gestational age (SGA) or large for gestational age (LGA)
  • Inborn errors of metabolism
  • History of necrotizing enterocolitis Bell stage III
  • Cerebrospinal fluid indwelling shunt (affects body composition measurements)
  • Expected death prior to 36 weeks EGA (the end of the study period)
  • Inability to meet Pea Pod® requirements for the first measurement
  • On vasopressor medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OUHSC Children's Hospital

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (1)

  • Atchley CB, Cloud A, Thompson D, Blunt MH, Satnes KJ, Szyld E, Ernst KD. Enhanced Protein Diet for Preterm Infants: A Prospective, Randomized, Double-blind, Controlled Trial. J Pediatr Gastroenterol Nutr. 2019 Aug;69(2):218-223. doi: 10.1097/MPG.0000000000002376.

    PMID: 31058772DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Courtney B Atchley, DO

    OUHSC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 2, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

December 22, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)