Feeding and Swallowing Problems in Infa… | Clinical Trial

Key information

Conditions

Feeding Disorders Cartilage Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Feeding and Eating Disorders Gastrointestinal Diseases Laryngeal Diseases Laryngomalacia Mental Disorders Musculoskeletal Abnormalities Musculoskeletal Diseases Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Digestive Skin and Connective Tissue Diseases Swallowing Disorder

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Sohag University Hospitals

Sohag, Sohag Governorate, 82524, Egypt

About this study

Identification of swallowing and feeding disorders in infants with laryngomalacia.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Mansoura Early Feeding Skills Assessment (MEFSA)

Time frame: 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.
Fibreoptic Endoscopic Evaluation of swallowing (FEES)

Time frame: 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 outcomes

The Functional Oral Intake Scale- Suckle Feeds and Transitional Feeds (FOIS-SFTF)

Time frame: 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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Apr 20, 2022
Registry last updated: Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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