Effect of Supplemental Feeding Tube Devices in Breastfeeding Success and Mother's Breastfeeding Self-Efficacy

NCT05802095 | Completed

• 1 other identifier: Urfa
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The research will be carried out as a randomized controlled experimental design to evaluate the effectiveness of the breastfeeding support system to increase sucking success in premature infants receiving care in the NICU and breastfeeding self-efficacy in mothers. In the study, the experimental and control groups will be determined by randomization of premature babies hospitalized in the NICU. While the babies in the control group will be fed with the routine feeding method (bottle) of the NICU, the babies in the experimental group will be fed with the breastfeeding support system by their mother. Research data will be collected using the Premature Baby and Its Mother Information Form, Premature Baby Follow-up Form, LATCH Breastfeeding Diagnostic Scale and Breastfeeding Self-Efficacy Scale-Short Form.

Conditions

Breastfeeding; Feeding Disorder Neonatal

Keywords

neonatal feeding; breastfeeding; supplemental feeding tube device

Outcome Measures

Primary Outcomes (2)

• LATCH a breastfeeding charting system and documentation tool

  LATCH is a diagnostic tool whose scoring system is similar to the Apgar score system. The scale consists of five evaluation criteria. The LATCH diagnostic tool is formed from the English initials of these five criteria. For each criterion that makes up the LATCH Breastfeeding Diagnostic and Evaluation Scale, 0,1, 2 points are given. Breastfeeding success is evaluated by summing the scores. The highest score that can be obtained from the scale is 10 and the lowest score is 0. The higher the score obtained from the scale, the higher the success of breastfeeding. In the research, the mother and her baby will be observed and evaluated while breastfeeding.

  1 hours

• Breastfeeding Self-Efficacy Short Form Scale

  The scale is in 5-point Likert type and the items of the scale are evaluated by grading from 1 "I am not sure" to 5 "I am always sure". The lowest score that can be obtained from the scale is 14, and the highest score is 70. A high score on the scale indicates higher breastfeeding self-efficacy.

  1 hours

Study Arms (2)

Experimental group

EXPERIMENTAL

The babies in the experimental group are fed 3 meals from the day after the decision to switch to oral feeding, with supplemental feeding tube device(SFTD) (09:00-12:00-15:00) and other meals with a bottle.

Device: Supplemental Feeding Tube Device

Control

NO INTERVENTION

The babies in the control group, on the other hand, will be fed 3 meals a day (09:00-12:00-15:00) after the decision to switch to oral feeding, which is the routine feeding method of the intensive care unit, and with a bottle for other meals in the same way.

Interventions

Supplemental Feeding Tube Device DEVICE

One end of the catheter is in such a way that milk comes into the bottle. The tip of the feeding catheter can be fixed to the mother's breast with a plaster so that it is in the baby's mouth. The tip of the catheter is placed inside the baby's mouth while the baby is sucking on its mother. While the mother is breastfeeding, milk is supplied to the baby from both the mother and the bottle. The baby will continue to suckle as he feels that plenty of milk is coming. To increase the flow of milk from the bottle, the mother hangs the bottle around her neck with the teat side down. The higher the bottle or milk container is held, the greater the flow of milk. It is an easy and safe method.

Experimental group

Eligibility Criteria

• Age: 32 Weeks - 35 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Postmenstrual age 32 and 35 weeks of gestation,
• Over 1500 g,
• Switching to oral feeding after feeding with orogastric tube,
• Who has been breastfed during gavage feeding,
• Those who have not completed the first 24 hours in the transition from oragastric tube feeding to the oral feeding process,
• Having cues of readiness for feeding (tolerating enteral nutrition, having a stable oxygen saturation and breathing during feeding, having the ability to lick, swallow and suck, react when mouth and lip are given stimuli),
• The mother's willingness to breastfeed her baby,
• Premature babies of parents who volunteered to participate in the study will be included.

You may not qualify if:

• Having diseases other than being premature
• Able to successfully take the breast in the first attempt,
• Congenital anomaly,
• Chromosomal disorders,
• Having sepsis
• With intracranial bleeding,
• Those with a very low birth weight below 1500 g and
• Less than 32nd gestational week,
• Premature babies older than 35 weeks of gestation will be excluded.

Sponsors & Collaborators

• Medipol University: lead

Study Sites (1)

Şanlıurfa Eğitim ve Araştırma Hastanesi

Sanliurfa, Turkey (Türkiye)

Location

Related Publications (1)

• Celik F, Sen S, Karayagiz Muslu G. Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants: A Randomized Controlled Trial. Clin Nurs Res. 2022 Jun;31(5):891-900. doi: 10.1177/10547738211058312. Epub 2021 Nov 16.

  PMID: 34784787 BACKGROUND

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Fatma Bozdağ

  Harran University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: İstanbul Medipol University

Model Details: Randomised Controlled Clinical Trial

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: May 2, 2023
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)