Swallowing Sound in Preterm Infant Evaluation of Feeding Maturation

Other Preterm Infants Clinical Trial

Official title:

Swallow Maturation in Preterm and Term Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944956
• Other study ID #: Baskent
• Secondary ID: swallowing sound
• Status: Completed
• Phase: N/A
• First received: September 11, 2013
• Last updated: September 15, 2013
• Start date: June 2011
• Est. completion date: March 2012

Study information

• Verified date: March 2011
• Source: Baskent University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 26 Weeks to 40 Weeks

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Other Preterm Infants
• Premature Birth

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baskent University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	swallow count	Mean MRS (mean±SD;17±7) for the preterm group reached the reference value at postmenstrual 38-40 weeks.	Participants will be followed up until postmenstrual 38-40 weeks, an expected avarage of 10 weeks	Yes