NCT01944956

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2013

Completed
Last Updated

September 18, 2013

Status Verified

March 1, 2011

Enrollment Period

9 months

First QC Date

September 11, 2013

Last Update Submit

September 15, 2013

Conditions

Other Preterm Infants

Keywords

Maturationpreterm infantssucking and swallowing

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age26 Weeks - 40 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Ince DA, Ecevit A, Acar BO, Saracoglu A, Kurt A, Tekindal MA, Tarcan A. Noninvasive evaluation of swallowing sound is an effective way of diagnosing feeding maturation in newborn infants. Acta Paediatr. 2014 Aug;103(8):e340-8. doi: 10.1111/apa.12686. Epub 2014 May 29.

    PMID: 24814215DERIVED

Study Officials

  • Deniz Anuk Ince, MD

    Baskent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 11, 2013

First Posted

September 18, 2013

Study Start

June 1, 2011

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 18, 2013

Record last verified: 2011-03