Effects of Oral Stimulation and Supplemental Nursing System

NCT05087043 | Completed

• 1 other identifier: 1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Breastfeeding

Keywords

Preterm; oral stimulation; supplemental nursing system

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• The discharge body weight

  The discharge body weight is the weight in grams of preterm babies at discharge

  up to 2 months

• The sucking success

  The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.

  In the first month after discharge

Secondary Outcomes (3)

• Heart rate of the babies

  15 minutes

• respiratory rate of the babies

  15 minutes

• oxygen saturation of the babies

  15 minutes

Study Arms (2)

Oral Stimulation and Supplemental Nursing System group

EXPERIMENTAL

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)

control group

NO INTERVENTION

The clinic's routine feeding protocol was applied to the babies in the control group.

Interventions

Oral motor stimulation (OMS) and The supplemental nursing system (SNS) DEVICE

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.

Oral Stimulation and Supplemental Nursing System group

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Gonca Muslu

Fethiye, Muğla, 48300, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• gonca muslu

  Muğla Sıtkı Koçman University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Faculty of Fethiye Health Science

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 21, 2021
• Study Start: February 1, 2018
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)