Effects of Oral Stimulation and Supplemental Nursing System

October 8, 2021 updated by: Gonca Karayagiz Muslu, Muğla Sıtkı Koçman University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Muğla
      • Fethiye, Muğla, Turkey, 48300
        • Gonca Muslu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oral Stimulation and Supplemental Nursing System group
Oral motor Stimulation (OMS) and an Supplemental Nursing System (SNS) were applied to preterm infants in the experimental group.
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.
No Intervention: control group
The clinic's routine feeding protocol was applied to the babies in the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
transition times to oral feeding
Time Frame: 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.
up to three weeks
transition times to full breast
Time Frame: 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
up to 15 days
the weight of the babies when they started oral nutrition
Time Frame: up to three weeks
. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
up to three weeks
the weight of the babies when they started full breastfeeding
Time Frame: 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
up to 15 days
the duration of the baby's discharge
Time Frame: 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
up to 2 months
The oral nutrition body weight
Time Frame: up to three weeks
The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
up to three weeks
The full breastfeeding body weight
Time Frame: 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.
up to 15 days
The discharge body weight
Time Frame: up to 2 months
The discharge body weight is the weight in grams of preterm babies at discharge
up to 2 months
The sucking success
Time Frame: In the first month after discharge
The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.
In the first month after discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate of the babies
Time Frame: 15 minutes
Heart rate
15 minutes
respiratory rate of the babies
Time Frame: 15 minutes
respiratory rate
15 minutes
oxygen saturation of the babies
Time Frame: 15 minutes
oxygen saturation
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Study Chair: gonca muslu, Muğla Sıtkı Koçman University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Actual)

June 15, 2018

Study Completion (Actual)

June 15, 2018

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

October 8, 2021

First Posted (Actual)

October 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 21, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1 (Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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