NCT06371443

Brief Summary

Underdeveloped oral structures of preterm infants cause feeding problems. Therefore, the development of sucking reflexes of premature babies should be supported. This study aimed to investigate the effect of suck-swallow training on the transition to oral feeding in premature infants. The study was conducted as a randomized controlled experimental trial in the NICU of a public hospital in Istanbul. The study sample consisted of 82 premature infants. Of these infants, 41 were assigned to the experimental group and 41 to the control group. Study data were collected using the investigator-developed Premature Infant Data Collection Form and Early Feeding Skills Assessment Tool. Throughout the study, preterm infants in the experimental group (n=41) were given suck-swallow exercises for 12 minutes once a day before feeding for 14 days. SPSS21 was used to analyze the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2022

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

April 17, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

August 19, 2022

Last Update Submit

July 2, 2024

Conditions

Keywords

Oral feedingsucking-swallowing exercisespremature Infant

Outcome Measures

Primary Outcomes (1)

  • The early feeding skills assessment tool (EFS)

    This scale is a reliable tool that assesses skills that contribute to safe and successful oral feeding of preterm infants in 5 sub-dimensions. Sub-dimensions include respiratory regulation, oral motor function, swallowing coordination, feeding participation, and physiological stability.

    December 2021 and June 2022

Study Arms (2)

experimental group

EXPERIMENTAL

41 premature infants in the experimental group

Behavioral: Sucking and swallowing exercises

control group

NO INTERVENTION

41 premature infants in the control group

Interventions

Sucking-swallowing exercises were applied to premature infants in the experimental group (n=41) for 14 days, once a day, 12 minutes before feeding.

experimental group

Eligibility Criteria

Age34 Weeks - 37 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Premature babies with an updated gestational week of 34 weeks
  • Premature babies born at 34-37 weeks of gestation
  • Premature babies with stable vital signs
  • Premature babies with underdeveloped sucking activity

You may not qualify if:

  • intubated babies
  • Babies with multiple anomalies
  • Babies with asphyxia
  • Infants with unstable vital signs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medipol University

Istanbul, Beykoz, 34810, Turkey (Türkiye)

Location

Related Publications (1)

  • Gokdemir E, Dogan AK. The Effect of Suckling and Swallowing Exercises During the Transition to Oral Feeding in Premature Infants: Randomized Controlled Study. Niger J Clin Pract. 2025 Jun 1;28(6):708-715. doi: 10.4103/njcp.njcp_41_25. Epub 2025 Jun 25.

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Elif Arslan

    Medipol University

    PRINCIPAL INVESTIGATOR
  • Aysel Kokcu Dogan

    Medipol University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 19, 2022

First Posted

April 17, 2024

Study Start

December 3, 2021

Primary Completion

June 1, 2022

Study Completion

August 1, 2022

Last Updated

July 3, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations