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

Ankara City Hospital

Status: Not yet enrolling

Conditions: Nutrition Disorders; Premature; Sucking Behavior

Treatments: Other: Oral stimulation; Other: Pacifier

Study type: Interventional

Funder types: Other

Identifiers

NCT05249179

E2-21-883

Details and patient eligibility

About

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.

Enrollment: 140 estimated patients

Sex: All

Ages: Under 6 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups

Group 1 (Oral stimulation)

Experimental group

Description:

The group that will receive oral stimulation with the Backman method once a day from the 29th week

Treatment:

Other: Oral stimulation

Group 2 (Pacifier)

Experimental group

Description:

The group that will be given a pacifier three times a day from the 29th week

Treatment:

Other: Pacifier

Group 3 (oral stimulation + pacifier)

Experimental group

Description:

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.

Treatment:

Other: Pacifier

Other: Oral stimulation

Group 4 (Enteral feeding by tube)

No Intervention group

Description:

The group fed enterally by tube in routine practice, in which no intervention will be made.