Comparison of the Effects of Oral Stimulation and Non-nutritive Sucking Practices
NCT ID: NCT05249179
Last Updated: 2022-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
140 participants
INTERVENTIONAL
2022-04-01
2024-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Group 1 (Oral stimulation)
The group that will receive oral stimulation with the Backman method once a day from the 29th week
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.
Group 2 (Pacifier)
The group that will be given a pacifier three times a day from the 29th week
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.
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.
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.
Group 4 (Enteral feeding by tube)
The group fed enterally by tube in routine practice, in which no intervention will be made.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Babies born with asphyxia
* Babies with major GIS anomalies
* Babies who have undergone major GIS surgery
6 Months
ALL
No
Sponsors
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Ankara City Hospital Bilkent
OTHER
Responsible Party
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Principal Investigators
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Nilgün Altuntas, Proff
Role: STUDY_DIRECTOR
Ankara Bilkent Central Hospital, Neonatal Unit
Suna S Oguz, Proff
Role: STUDY_DIRECTOR
Ankara Bilkent Central Hospital, Neonatal Unit
Mustafa S Akin, Specialist
Role: STUDY_DIRECTOR
Ankara Bilkent Central Hospital, Neonatal Unit
Central Contacts
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Other Identifiers
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E2-21-883
Identifier Type: -
Identifier Source: org_study_id
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