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

Nutrition Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05249179
• Other study ID #: E2-21-883
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: August 1, 2024

Study information

• Verified date: December 2021
• Source: Ankara City Hospital Bilkent
• Contact: Mustafa S Akin, Specialist
• Phone: +90 555 876 05 85
• Email: mustafasenolakin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Nutrition Disorders
• Premature
• Sucking Behavior

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hospital stay (days)	The effect of oral stimulation and/or pacifier use on hospital stay in premature infants	2 years