Impact of Feeding Interval of Preterms on the Time of Transition From Tube Feeding to Oral Feeding

August 13, 2017 updated by: Sezin Unal, Etlik Zubeyde Hanim Womens' Health and Teaching Hospital
Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials. Investigators aimed to investigate the impact of 2-hourly feeding on time of transition from orogastric to oral feeding.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Preterms are usually fed with intervals of either two or three hours during their stay in neonatal intensive care unit. Recommendations of World Health Organization about feeding regimens, 3-hourly for infants 1500 - 2000 gr, and 2-hourly for infants 1000 - 1500 gr, are not proposed with regards to results of randomized controlled trials.

Stomach volume of preterms varies a wide range of upto 20 ml. This should be taken into consideration during the process of feeding of preterms in neonatal intensive care unit. Trials were focused on early neonatal outcomes and it was found that duration of phototherapy and nasal noninvasive ventilation, and time to achieve full enteral feeds were shorter during 2-hourly feeding when compared to 3-hourly feeding, on the other hand 3-hourly feeding was shown to accelerate the stomach emptying. Besides, duration of catheterization, and ratio of feeding intolerance, apnea, and hypoglycemia were found to be similar infants who fed either 2 or 3-hourly.

Investigators aimed to investigate the impact of two feeding regimens, 2-hourly or 3-hourly, on time of transition from orogastric to oral feeding in preterms.

Patients and Methods: Preterms of birth weight less that 1500 gr and gestational age smaller than 32 weeks are going to be eligible for study if no congenital anomalies exist. Regarding current clinical protocol infants are fed every 2 hours until they weigh 1500 gr, and every 3 hours afterwards. At the day that the infants reach 1500 gr of body weight, a randomization will be performed in to two groups, Intervention group: Q2 interval (2-hourly feeding) or Control group: Q3 interval (3-hourly feeding), due to study protocol. Infants with inherited metabolic disorders, congenital anomalies, neonatal sepsis, and surgical diseases and the ones who fed with exclusively formula will be excluded.

After randomization infants will be followed until discharge. The type of feeding, volume of each feed, weight gain per week, feeding intolerance (abdominal distention, vomiting, apnea, newly onset or increase of oxygen treatment demand), day of first oral feeding, time of transition from orogastric tube to oral feeding, duration of hospitalization will be recorded.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

  • Turkey
      • Ankara, Turkey, 06010
        • EtlikWHTH

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

1 week to 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. birth weight <= 1500 gr gr
  2. gestational age <= 32 weeks
  3. postnatal age at randomization: between 7 - 90 days

Exclusion Criteria:

  • congenital anomaly
  • multi organ failure
  • sepsis
  • surgical pathology
  • inherited metabolic diseases
  • exclusively formula 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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Q2 feeding
feeding intervals: 2 hours
Other: Q2 feeding
Infants are going to be fed every 2 hours
NO_INTERVENTION: Q3feeding
feeding intervals: 3 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
time of transition from orogastric to oral feeding
Time Frame: From date of birth to date of transition from orogastric to oral feeding or date of death, which ever came first, will be assessed up to 44th post menstrual age (days of life)
From date of birth to date of transition from orogastric to oral feeding or date of death, which ever came first, will be assessed up to 44th post menstrual age (days of life)

Secondary Outcome Measures

Outcome Measure
Time Frame
feeding intolerance after randomization; intolerance events per week until discharge
Time Frame: From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age
From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age
duration of hospitalization
Time Frame: From date of birth to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (days of life)
From date of birth to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (days of life)
weight gain per week until discharge
Time Frame: From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (grams/kg/week)
From date of randomization to date of discharge or date of death, which ever came first, will be assessed up to 44th post menstrual age, (grams/kg/week)

Collaborators and Investigators

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

Sponsor

Etlik Zubeyde Hanim Womens' Health and Teaching Hospital

Investigators

  • Principal Investigator: Sezin Unal, MD, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

September 30, 2016

Primary Completion (ACTUAL)

May 31, 2017

Study Completion (ACTUAL)

August 1, 2017

Study Registration Dates

First Submitted

September 8, 2016

First Submitted That Met QC Criteria

September 25, 2016

First Posted (ESTIMATE)

September 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 16, 2017

Last Update Submitted That Met QC Criteria

August 13, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EZH/2015/4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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