Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants

March 23, 2021 updated by: Mohammed Khalaf Ali, Assiut University

Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants: a Prospective Study at Neonatology Unit of Assiut University Children Hospital

The aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

It is widely acknowledged that pre-term infants frequently experience difficulties in attaining independent oral feeding, thus delaying the achievement of an adequate nutritional status and hospital discharge which - according to the American Academy of Pediatrics- requires the ability to feed exclusively by mouth(1-2) The development of oral feeding ability in pre-term infants is therefore a primary concern for neonatologists.

Because of the immaturity of their body functions and the occurrence of co-morbidities, pre-term infants generally require a period of enteral feeding before they acquire the coordinated sucking ability that allows sufficient milk intake for growth(3) Furthermore, infant sucking skills differ between bottle- and breastfeeding (4), and pre-term infants have been reported to show a weaker and less coordinated suck (5).

Few studies have investigated the timing and effect of co-morbidities on the achievement of independent oral skills. Jadcherla et al. (6) reported that infants born with a gestational age of < 28 weeks showed a significant delay in attaining the transition to oral feeding, but it has also been found that the occurrence of morbidities negatively correlates with postmenstrual age at the time of achieving oral feeding skills (6),(7-8).

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

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

Study Contact

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 day (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Newborns whose gestational age of < 37 weeks.

Description

Inclusion Criteria:

  1. A randomised sample of all newborns whose gestational age of < 37 weeks .
  2. infants who will be admitted to the NICU of Assiut University Children Hospital between 1 May and 31 October 2021.

Exclusion Criteria:

  1. known congenital and/or chromosomal diseases.
  2. death during hospitalisation, or transfer to another institution.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mean post-menstrual age in weeks at the time of starting and achieving full oral feeding will be evaluated
Time Frame: Baseline
Statistical analysis will be made using SPSS version 12 software to assess the outcomes
Baseline

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Mostafa Shafeek, Assiut University

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 (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

October 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

March 22, 2021

First Posted (Actual)

March 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Oral feeding in preterms

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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