Swallowing Sound in Preterm Infant Evaluation of Feeding Maturation

Completed

• Conditions: Other Preterm Infants

• Registration Number: NCT01944956
• Lead Sponsor: Baskent University

Brief Summary

Our objective was to evaluate maturation of sucking and swallowing in preterm infants using a non-invasive method: assessment of swallowing sounds. Findings in healthy term infants were used as reference values.

Detailed Description

Successful transition to full oral feeding in preterm infants is important for safe discharge from hospital and for facilitating the mother-infant bond. Preterm infants were evaluated weekly for sucking and swallowing performance (i.e., feeding performance) from the time they began oral feeding (frequency 1-2 oral feedings/day) until they reached independent oral feeding (frequency 8 oral feedings/day) at postmenstrual 38-40 weeks. For the term infants, we evaluated a single oral feeding during the first week of life.

The exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis. Each swallowing-sound recording was 2 minutes long and was captured in a quiet environment by the same investigator. The feeding parameters generated from the recordings were as follows: total number of swallows (S), total number of rhythmic swallows (RS), total number of resting intervals (RI), average time between resting intervals (ATRI), average time between swallows (ATS), average time between rhythmic swallows (ATRS), maximum number of rythymic swallows (MRS), and volume of milk ingested (VM) during the 2-minute evaluation.

Study Timeline

• Status Verified: 2011-03
• Study Start: 2011-06
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Study First Submitted: 2013-09-11
• Study First Submitted QC: 2013-09-15
• Last Update Submitted: 2013-09-15
• Study First Posted: 2013-09-18
• Last Update Posted: 2013-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• Preterm infants (< 37 gestational weeks) and term infants (>=37 gestational weeks)

Exclusion Criteria

• The exclusion criteria were major congenital abnormalities, craniofacial malformation, intracranial hemorrhage, bronchopulmonary dysplasia, culture-positive sepsis, and necrotizing enterocolitis.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
swallow count	Participants will be followed up until postmenstrual 38-40 weeks, an expected avarage of 10 weeks	Mean MRS (mean±SD;17±7) for the preterm group reached the reference value at postmenstrual 38-40 weeks.