Feeding and Swallowing Problems in Infants With Laryngomalacia

Sponsor
Sohag University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05337475
Collaborator
(none)
30
1
25
1.2

Study Details

Study Description

Brief Summary

Observational cross-sectional study Infants with laryngomalacia Feeding and swallowing assessment

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Identification of swallowing and feeding disorders in infants with laryngomalacia.

    Identify if there is relation between severity of laryngomalacia and feeding and swallowing disorder.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Feeding and Swallowing Problems in Infants With Laryngomalacia
    Actual Study Start Date :
    May 1, 2022
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Mansoura Early Feeding Skills Assessment (MEFSA) [2 years]

      an 85-item observational measure of oral feeding skill. It will be used for assessing oral feeding through maturation of oral feeding skill. The MEFSA includes 3 main sections; pre-feeding, during feeding and post-feeding sections. The "during feeding" section, "Oral Feeding Maintenance" will be used in this study which supports infant based feeding that give the infant opportunity to communicate and express stress signals that must be respected. It proposed to observe the infant from moment to moment during feeding. This section composed of 30 items to assess infant abilities to (a) remain engaged in feeding, (b) organize oral-motor skills, (c) maintain physiologic stability and (d) coordinate SSB.

    2. Fibreoptic Endoscopic Evaluation of swallowing (FEES) [2 years]

      FEES will be done with presentations of food and/or milk consistency (Secretions, thin and thick fluids, puree and/or solids) to obtain multiple trials of each texture. Infants who are fed only milk, FEES will be performed either with bottle-feeding or 5ml syringe (without needle) with the milk. Each infant will be fed by his or her typical caregiver or by the nurse. The feeding protocol began by presenting the infants with the bottle and/or nipple. If no aspiration occurred on the initial swallows, then the infant will be allowed to suck on the bottle until there was a change in swallowing function, 60 ml was finished, or the infant refused to suck.

    Secondary Outcome Measures

    1. The Functional Oral Intake Scale- Suckle Feeds and Transitional Feeds (FOIS-SFTF) [2 years]

      score (1) stand for nothing by mouth, score (2) Tube dependent, with minimal attempts at liquids or food, score (3) Tube dependent, with consistent intake of liquids or food, score (4) Total oral diet, but requiring special preparation of liquids (ie, thickened liquids) +/- compensations, score (4.5) Total oral diet, but requiring special preparation of solids (eg, foods of different texture and/or liquid supplements) +/- compensations, score (5) Total oral diet, without special preparation (ie, regular thin fluids, foods of same texture as peers, and no additional liquid supplements), but with compensations, score (6) Total oral diet, with no restrictions

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Month to 24 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Infants up to 2 years old diagnosed with laryngomalacia.

    • Full term infants.

    Exclusion criteria:
    • Infants with other possible causes of dysphagia e.g., craniofacial anomalies, BDMH and neurological affection secondary to birth trauma, hypoxic ischemic encephalopathy and other brain insults.

    • Infants who were lethargic and/or medically unstable and were generally unable to participate to protocol of assessment.

    • Premature infants.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sohag University Hospitals Sohag سوهاج Egypt 82524

    Sponsors and Collaborators

    • Sohag University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amal Fouad Sayed, Principal Investigator, Sohag University
    ClinicalTrials.gov Identifier:
    NCT05337475
    Other Study ID Numbers:
    • Soh-Med-22-04-23
    First Posted:
    Apr 20, 2022
    Last Update Posted:
    Jun 7, 2022
    Last Verified:
    Jun 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 7, 2022