Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices

Not Applicable

• Conditions: Nutrition Disorders; Sucking Behavior; Premature
• Interventions: Other: Pacifier; Other: Oral stimulation

• Registration Number: NCT05249179
• Lead Sponsor: Ankara City Hospital Bilkent

Brief Summary

This study, it was aimed to compare the effects of oral stimulation and non-nutritive sucking practices on the transition to full oral feeding in babies with a gestational age of 26-32 weeks. Non-oral feeding methods are frequently used in babies born prematurely since sucking and sucking-swallowing coordination have not yet developed. While some premature babies gain the sucking and swallowing reflexes faster, some of them cannot develop this reflex for a long time, so the length of hospital stay is prolonged. All infants who can be fed completely enterally (PMA \>29 weeks) will be randomized into 4 groups as oral stimulation (group 1), pacifier (group 2), oral stimulation + pacifier (group 3), and control group by using a stratified blocked randomization method with a block size of 4. Stratification on GA (26-27, 28-29, 30-32 weeks GA) was used to ensure that the groups had similar gestational age distribution. The time of the patients to start breastfeeding and the length of hospital stay (days) will be compared.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-11
• Study First Submitted QC: 2022-02-18
• Last Update Submitted: 2022-02-18
• Study First Posted: 2022-02-21
• Last Update Posted: 2022-02-21
• Study Start: 2022-04-01
• Primary Completion: 2024-01-01
• Study Completion: 2024-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Preterm babies born between 26-32 weeks (including 26 and 32 weeks)

Exclusion Criteria

• Babies with congenital anomalies
• Babies born with asphyxia
• Babies with major GIS anomalies
• Babies who have undergone major GIS surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3 (oral stimulation + pacifier)	Pacifier	Starting from the 29th week, the group will be given a pacifier three times a day and a Backman oral stimulation will be applied once a day.
Group 1 (Oral stimulation)	Oral stimulation	The group that will receive oral stimulation with the Backman method once a day from the 29th week
Group 2 (Pacifier)	Pacifier	The group that will be given a pacifier three times a day from the 29th week
Group 3 (oral stimulation + pacifier)	Oral stimulation	Starting from the 29th week, the group will be given a pacifier three times a day and a Backman oral stimulation will be applied once a day.

Primary Outcome Measures

Name	Time	Method
Full oral feeding time (postmenstruel week)	2 years	The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.
Hospital stay (days)	2 years	The effect of oral stimulation and/or pacifier use on hospital stay in premature infants