Effects of Oral Stimulation and Supplemental Nursing System

Breastfeeding Clinical Trial

Official title:

Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05087043
• Other study ID #: 1
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: June 15, 2018

Study information

• Verified date: October 2021
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 15, 2018
• Est. primary completion date: June 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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

Related Conditions & MeSH terms

• Breastfeeding

Intervention

Device:
• Oral motor stimulation (OMS) and The supplemental nursing system (SNS)
OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster.

Locations

Country	Name	City	State
Turkey	Gonca Muslu	Fethiye	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	transition times to oral feeding	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.	up to three weeks
Primary	transition times to full breast	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	up to 15 days
Primary	the weight of the babies when they started oral nutrition	. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.	up to three weeks
Primary	the weight of the babies when they started full breastfeeding	The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone	up to 15 days
Primary	the duration of the baby's discharge	The duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge	up to 2 months
Primary	The oral nutrition body weight	The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.	up to three weeks
Primary	The full breastfeeding body weight	The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone.	up to 15 days
Primary	The discharge body weight	The discharge body weight is the weight in grams of preterm babies at discharge	up to 2 months
Primary	The sucking success	The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.	In the first month after discharge
Secondary	Heart rate of the babies	Heart rate	15 minutes
Secondary	respiratory rate of the babies	respiratory rate	15 minutes
Secondary	oxygen saturation of the babies	oxygen saturation	15 minutes