Initiation of Oral Feeding at 30 Versus 33 Weeks Postmenstrual Age

May 12, 2016 updated by: Kathleen Kennedy, The University of Texas Health Science Center, Houston
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Infants will be enrolled and randomized at 30 0/7 weeks postmenstrual age. The Earlier Oral Feeding group will initiate oral feedings at 30 0/7 weeks postmenstrual age. The Later Oral Feeding group will initiate oral feedings at 33 0/7 weeks postmenstrual age. The number of oral feeding attempts will be advanced according to a feeding progression protocol for both groups. Successful completion of a feeding is defined as oral completion of the full volume of a feeding within 30 minutes, without a bradycardic episode (heart rate <100 beats per minute) or desaturation (oxygen saturation decrease >5% from baseline values). If infant does not successfully complete >95% of the total prescribed volume of a feeding, the remainder of the volume will be supplied via gastric tube. All oral feedings will be performed by bedside nurses, or by a parent with observation by the nursing staff, with continuous cardiorespiratory and pulse oximetry monitoring. Individual oral feeding attempts for both groups will continue until one of the following occurs despite appropriate pacing of the feeding: 1) the feeding is completed 2) feeding duration of 30 minutes 3) adverse event during a feeding [multiple bradycardic episodes (3 episodes of heart rate <100 beats per minute), bradycardia with choking episode, single severe bradycardia (heart rate <60)]. If the infant experiences an adverse event during an oral feeding attempt, oral feeding attempts will be held for 2 days.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Houston, Texas, United States, 77030
        • Children's Memorial Hermann Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 30 weeks
initiation of oral feedings at 30 weeks
Active Comparator: 33 weeks
initiation of oral feedings at 33 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postmenstrual age at full oral feeding
Time Frame: until hospital discharge (typically 36 weeks postmenstrual age)
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 Outcome Measures

Outcome Measure
Time Frame
postmenstrual age at discharge
Time Frame: until hospital discharge (typically 36 weeks postmenstrual age)
until hospital discharge (typically 36 weeks postmenstrual age)
growth between enrollment and 36 weeks postmenstrual age
Time Frame: until hospital discharge (typically 36 weeks postmenstrual age)
until hospital discharge (typically 36 weeks postmenstrual age)

Other Outcome Measures

Outcome Measure
Time Frame
average FiO2
Time Frame: at 33 weeks postmenstrual age
at 33 weeks postmenstrual age
use of positive pressure (yes/no)
Time Frame: 33 weeks postmenstrual age
33 weeks postmenstrual age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

February 4, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • Age of Oral Feeding

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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