NCT01787019

Brief Summary

The purpose of the study is to determine if earlier initiation of oral (by mouth as opposed to tube) feedings in premature infants results in earlier attainment of full oral feedings and/or discharge.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2013

Typical duration for phase_2

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

January 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 8, 2013

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

3.2 years

First QC Date

February 4, 2013

Last Update Submit

May 12, 2016

Conditions

Prematurity

Outcome Measures

Primary Outcomes (1)

  • Postmenstrual age at full oral feeding

    defined as the infant orally consuming the volume of formula/breastmilk as prescribed by the attending physician without requiring gavage feedings for 2 days

    until hospital discharge (typically 36 weeks postmenstrual age)

Secondary Outcomes (2)

  • postmenstrual age at discharge

    until hospital discharge (typically 36 weeks postmenstrual age)

  • growth between enrollment and 36 weeks postmenstrual age

    until hospital discharge (typically 36 weeks postmenstrual age)

Other Outcomes (2)

  • average FiO2

    at 33 weeks postmenstrual age

  • use of positive pressure (yes/no)

    33 weeks postmenstrual age

Study Arms (2)

30 weeks

EXPERIMENTAL

initiation of oral feedings at 30 weeks

Other: Oral feeding

33 weeks

ACTIVE COMPARATOR

initiation of oral feedings at 33 weeks

Other: Oral feeding

Interventions

Oral feedingOTHER
30 weeks33 weeks

Eligibility Criteria

AgeUp to 7 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Gestational age \<= 29 weeks at birth
  • Tolerating enteral feedings for at least 3 days before 30 weeks postmenstrual age

You may not qualify if:

  • Neurologic, cardiac, respiratory, or gastrointestinal disorders that interfere with oral feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pediatrics

Study Record Dates

First Submitted

February 4, 2013

First Posted

February 8, 2013

Study Start

January 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations

US(1)