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

• Conditions: Feeding; Difficult, Newborn; Pre-Term

• Registration Number: NCT04812249
• Lead Sponsor: Assiut University

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.

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 Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-22
• Study First Posted: 2021-03-23
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-25
• Study Start: 2021-05-01
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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