NCT02377050

Brief Summary

The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 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

First Submitted

Initial submission to the registry

December 1, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

3.4 years

First QC Date

December 1, 2014

Last Update Submit

June 14, 2018

Conditions

Infant Premature

Keywords

Nutritional support

Outcome Measures

Primary Outcomes (1)

  • Weight gain

    Average change in weight between baseline and 12 weeks

    baseline to average 12 weeks of age

Secondary Outcomes (9)

  • Mid arm circumference

    baseline to average 12 weeks of age

  • Length

    baseline to average 12 weeks of age

  • Head circumference

    baseline to average 12 weeks of age

  • Caloric intake

    36 weeks

  • Length of stay

    36 weeks or discharge

  • +4 more secondary outcomes

Other Outcomes (8)

  • Body fat composition

    36 weeks or discharge

  • Rates of necrotizing enterocolitis (Bell Stage ≥ 2)

    36 weeks or discharge

  • Rates of feeding intolerance

    36 weeks or discharge

  • +5 more other outcomes

Study Arms (2)

Higher Volume Feeding Goal

ACTIVE COMPARATOR

Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day.

Other: Higher Volume Feeding Goal

Usual Volume Feeding Goal

NO INTERVENTION

Infants randomized to this group will have feeding goals of 140-160 ml/kg/day.

Interventions

Higher Volume Feeding GoalOTHER

feeding volume goal of 180-200 ml/kg/day

Higher Volume Feeding Goal

Eligibility Criteria

Age1 Day - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks

You may not qualify if:

  • Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

Related Publications (2)

  • Salas AA, Travers CP, Jerome ML, Chandler-Laney P, Carlo WA. Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth. J Pediatr. 2021 Mar;230:251-254.e3. doi: 10.1016/j.jpeds.2020.11.028. Epub 2020 Nov 25.

    PMID: 33248115DERIVED

  • Travers CP, Wang T, Salas AA, Schofield E, Dills M, Laney D, Yee A, Bhatia A, Winter L, Ambalavanan N, Carlo WA. Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial. J Pediatr. 2020 Sep;224:66-71.e1. doi: 10.1016/j.jpeds.2020.05.033. Epub 2020 May 25.

    PMID: 32464224DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Officials

  • Waldemar A Carlo, MD

    University of Alabama at Birmingham

    STUDY DIRECTOR

  • Colm Travers, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

  • Ariel A Salas, MD

    University of Alabama at Birmingham

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 1, 2014

First Posted

March 3, 2015

Study Start

January 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 18, 2018

Record last verified: 2018-06

Locations

US(1)