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

NCT05249179 | Unknown DMC

• 1 other identifier: E2-21-883
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Premature; Nutrition Disorders; Sucking Behavior

Keywords

Sucking; Oral stimulation; Premature baby

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

Group 1 (Oral stimulation)

EXPERIMENTAL

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

Other: Oral stimulation

Group 2 (Pacifier)

EXPERIMENTAL

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

Other: Pacifier

Group 3 (oral stimulation + pacifier)

EXPERIMENTAL

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: Pacifier; Other: Oral stimulation

Group 4 (Enteral feeding by tube)

NO INTERVENTION

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

Interventions

Pacifier OTHER

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 2 (Pacifier); Group 3 (oral stimulation + pacifier)

Oral stimulation OTHER

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 1 (Oral stimulation); Group 3 (oral stimulation + pacifier)

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm babies born between 26-32 weeks (including 26 and 32 weeks)

You may not qualify if:

• Babies with congenital anomalies
• Babies born with asphyxia
• Babies with major GIS anomalies
• Babies who have undergone major GIS surgery

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

MeSH Terms

Conditions

Premature Birth; Nutrition Disorders; Sucking Behavior

Interventions

Pacifiers

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Infant Equipment; Equipment and Supplies

Study Officials

• 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 DIRECTOR

Central Study Contacts

Mustafa S Akin, Specialist

CONTACT

+90 555 876 05 85; mustafasenolakin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2021
• First Posted: February 21, 2022
• Study Start: April 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: February 21, 2022

Record last verified: 2021-12