Effects of Oral Stimulation and Supplemental Nursing System

Not Applicable

Completed

• Conditions: Breastfeeding
• Interventions: Device: Oral motor stimulation (OMS) and The supplemental nursing system (SNS)

• Registration Number: NCT05087043
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.

Detailed Description

This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Study First Submitted: 2021-09-15
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• a birth weight of 1,000 gr and above,
• a gestational age between 30 and 34 weeks,
• no congenital anomaly,
• no severe asphyxia or chronic lung disease,
• spontaneous breathing,
• grades III and IV intracranial hemorrhage and no periventricular leukomalacia

exclusion criteria.

• congenital anomaly
• grades III and IV intracranial hemorrhage and periventricular leukomalacia

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Stimulation and Supplemental Nursing System group	Oral motor stimulation (OMS) and The supplemental nursing system (SNS)	Oral motor Stimulation (OMS) and an Supplemental Nursing System (SNS) were applied to preterm infants in the experimental group.

Primary Outcome Measures

Name	Time	Method
transition times to oral feeding	up to three weeks	Transition time to oral feeding is the time that the preterm baby outgrew gavage feeding and fed with complementary nutritional support, and it was evaluated as days in the study.
transition times to full breast	up to 15 days	The transition time to full breastfeeding is the duration from the day that the preterm baby started oral nutrition until the day they started breastfeeding
the weight of the babies when they started oral nutrition	up to three weeks	. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
the weight of the babies when they started full breastfeeding	up to 15 days	The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone
the duration of the baby's discharge	up to 2 months	The duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge
The oral nutrition body weight	up to three weeks	The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
The full breastfeeding body weight	up to 15 days	The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone.
The discharge body weight	up to 2 months	The discharge body weight is the weight in grams of preterm babies at discharge
The sucking success	In the first month after discharge	The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.

Secondary Outcome Measures

Name	Time	Method
Heart rate of the babies	15 minutes	Heart rate
respiratory rate of the babies	15 minutes	respiratory rate
oxygen saturation of the babies	15 minutes	oxygen saturation

Trial Locations

Locations (1)

Gonca Muslu; 🇹🇷 Fethiye, Muğla, Turkey