Back to results

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

Primary Purpose

Premature, Nutrition Disorders, Sucking Behavior

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Pacifier

Oral stimulation

About this trial

This is an interventional supportive care trial for Premature focused on measuring Sucking, Oral stimulation, Premature baby

Eligibility Criteria

undefined - 6 Months (Child)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Arm Label

Group 1 (Oral stimulation)

Group 2 (Pacifier)

Group 3 (oral stimulation + pacifier)

Group 4 (Enteral feeding by tube)

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

Full oral feeding time (postmenstruel week)

The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.

Hospital stay (days)

The effect of oral stimulation and/or pacifier use on hospital stay in premature infants

Secondary Outcome Measures

Full Information

NCT ID

NCT05249179

First Posted

December 11, 2021

Last Updated

February 18, 2022

Sponsor

Ankara City Hospital Bilkent

1. Study Identification

Unique Protocol Identification Number

NCT05249179

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

January 1, 2024 (Anticipated)

Study Completion Date

August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ankara City Hospital Bilkent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature, Nutrition Disorders, Sucking Behavior

Keywords

Sucking, Oral stimulation, Premature baby

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1 (Oral stimulation)

Arm Type

Experimental

Arm Description

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

Arm Title

Group 2 (Pacifier)

Arm Type

Experimental

Arm Description

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

Arm Title

Group 3 (oral stimulation + pacifier)

Arm Type

Experimental

Arm 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.

Arm Title

Group 4 (Enteral feeding by tube)

Arm Type

No Intervention

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Pacifier

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Oral stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Full oral feeding time (postmenstruel week)

Description

The effect of oral stimulation and/or pacifier use on full oral feeding time in premature infants.

Time Frame

2 years

Title

Hospital stay (days)

Description

The effect of oral stimulation and/or pacifier use on hospital stay in premature infants

Time Frame

2 years

10. Eligibility

Sex

All

Maximum Age & Unit of Time

6 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mustafa S Akin, Specialist

Phone

+90 555 876 05 85

mustafasenolakin@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nilgün Altuntas, Proff

Organizational Affiliation

Ankara Bilkent Central Hospital, Neonatal Unit

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Suna S Oguz, Proff

Organizational Affiliation

Ankara Bilkent Central Hospital, Neonatal Unit

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mustafa S Akin, Specialist

Organizational Affiliation

Ankara Bilkent Central Hospital, Neonatal Unit

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

No agreement yet to share with other researchers

Learn more about this trial

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

We'll reach out to this number within 24 hrs