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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05249179
Enrollment
140
Registered
2022-02-21
Start date
2022-04-01
Completion date
2024-08-01
Last updated
2022-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nutrition Disorders, Premature, Sucking Behavior

Keywords

Sucking, Oral stimulation, Premature baby

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.

Interventions

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.

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.

Sponsors

Ankara City Hospital Bilkent
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Full oral feeding time (postmenstruel week)2 yearsThe effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.
Hospital stay (days)2 yearsThe effect of oral stimulation and/or pacifier use on hospital stay in premature infants

Contacts

Primary ContactMustafa S Akin, Specialist
mustafasenolakin@gmail.com+90 555 876 05 85

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026