## Protocol Section
### Identification Module
**NCT ID:** 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

#### Organization Study ID Info
**ID:** E2-21-883
#### Organization
**Class:** OTHER
**Full Name:** Ankara City Hospital Bilkent
### Status Module
#### Completion Date
**Date:** 2024-08-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-02-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-02-18

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-01-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-04-01

**Type:** ESTIMATED

**Status Verified Date:** 2021-12

#### Study First Post Date
**Date:** 2022-02-21
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-11
**Study First Submit QC Date:** 2022-02-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Ankara City Hospital Bilkent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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 Module

**Conditions:**

- Premature

- Nutrition Disorders

- Sucking Behavior

**Keywords:**

- Sucking

- Oral stimulation

- Premature baby

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 140

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Oral stimulation

**Label:** Group 1 (Oral stimulation)

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Other: Pacifier

**Label:** Group 2 (Pacifier)

**Type:** EXPERIMENTAL

#### Arm Group 3

**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.

**Intervention Names:**

- Other: Pacifier

- Other: Oral stimulation

**Label:** Group 3 (oral stimulation + pacifier)

**Type:** EXPERIMENTAL

#### Arm Group 4

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

**Label:** Group 4 (Enteral feeding by tube)

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Group 2 (Pacifier)

- Group 3 (oral stimulation + pacifier)

**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.

**Name:** Pacifier

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Group 1 (Oral stimulation)

- Group 3 (oral stimulation + pacifier)

**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.

**Name:** Oral stimulation

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Full oral feeding time (postmenstruel week)

**Time Frame:** 2 years

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

**Measure:** Hospital stay (days)

**Time Frame:** 2 years

### Eligibility Module

**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

**Maximum Age:** 6 Months

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mustafasenolakin@gmail.com

**Name:** Mustafa S Akin, Specialist

**Phone:** +90 555 876 05 85

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Ankara Bilkent Central Hospital, Neonatal Unit

**Name:** Nilgün Altuntas, Proff

**Role:** STUDY_DIRECTOR

**Official 2:**

**Affiliation:** Ankara Bilkent Central Hospital, Neonatal Unit

**Name:** Suna S Oguz, Proff

**Role:** STUDY_DIRECTOR

**Official 3:**

**Affiliation:** Ankara Bilkent Central Hospital, Neonatal Unit

**Name:** Mustafa S Akin, Specialist

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** No agreement yet to share with other researchers

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M12684

- Name: Nutrition Disorders

- Relevance: HIGH

- As Found: Nutrition Disorders

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009748

- Term: Nutrition Disorders

### Misc Info Module

- Version Holder: 2024-05-24
