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Clinical Trials/NCT01944956
NCT01944956
Completed
Not Applicable

Swallow Maturation in Preterm and Term Infants

Baskent University0 sites94 target enrollmentJune 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Other Preterm Infants
Sponsor
Baskent University
Enrollment
94
Primary Endpoint
swallow count
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2011
End Date
March 2012
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Deniz Anuk Ince

Principal Investigator

Baskent University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

swallow count

Time Frame: 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.

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