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

Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices on the Transition to Full Oral Feeding in Infants With a Gestational Age of 26-32 Weeks

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutrition Disorders; Premature; Sucking Behavior
• Intervention / Treatment: Other: Oral stimulation; Other: Pacifier

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mustafa S Akin, Specialist; Phone Number: +90 555 876 05 85; Email: mustafasenolakin@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Oral stimulation); The group that will receive oral stimulation with the Backman method once a day from the 29th week	Other: Oral stimulation; Infants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue.
Experimental: Group 2 (Pacifier); The group that will be given a pacifier three times a day from the 29th week	Other: Pacifier; Preterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube.
Experimental: Group 3 (oral stimulation + 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.	Other: Oral stimulation; Infants in groups 1 and 3 will receive a prefeeding oral stimulation program once a day, 15 to 30 minutes before a tube feeding. Oral stimulation programs will be delivered by trained nurses or pediatric physical therapies. Nurses will be trained to deliver the stimulation program to the infants, by a member from the pediatric physical therapies medical staff, before the beginning of the study. Based on Backman's principles, the pre-feeding oral stimulation program consisted of a 12-minute stimulation program that included stroking the cheeks, lips, gums, and tongue.; Other: Pacifier; Preterm infants in Groups 2 and 3 will suck a pacifier 3 times a day (09:00, 12:00, 15:00) for 3 minutes before feeding and then they will be fed with the O/G feeding tube.
No Intervention: Group 4 (Enteral feeding by tube); The group fed enterally by tube in routine practice, in which no intervention will be made.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ankara City Hospital Bilkent
• Investigators: Study Director: Nilgün Altuntas, Proff, Ankara Bilkent Central Hospital, Neonatal Unit; Study Director: Suna S Oguz, Proff, Ankara Bilkent Central Hospital, Neonatal Unit; Study Director: Mustafa S Akin, Specialist, Ankara Bilkent Central Hospital, Neonatal Unit

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: December 11, 2021
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 21, 2022
• Last Update Submitted That Met QC Criteria: February 18, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Sucking; Oral stimulation; Premature baby
• Additional Relevant MeSH Terms: Nutrition Disorders
• Other Study ID Numbers: E2-21-883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: No agreement yet to share with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No