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

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04812249

Collaborator

(none)

160

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Feeding; Difficult, Newborn Pre-Term	Other: Clinical assessment

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 Design

Study Type:

Observational

Anticipated Enrollment :

160 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Day

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assiut University

Investigators

Study Director: Mostafa Shafeek, Assiut University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Mohammed Khalaf Ali, Assistant Lecturer, Assiut University

ClinicalTrials.gov Identifier:

NCT04812249

Other Study ID Numbers:

Oral feeding in preterms

First Posted:

Mar 23, 2021

Last Update Posted:

Mar 25, 2021

Last Verified:

Mar 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Mar 25, 2021