The Effect of the SNS-Based Feeding on Transition to Exclusive Breastfeeding in Preterm Infants

NCT05815706 | Completed

• 1 other identifier: 2018-1/20
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigated the effect of the Supplemental Nursing System (SNS)-based feeding on the time to transition to exclusive breastfeeding, sucking success, and the time to discharge in preterm infants

Conditions

Breastfeeding; Preterm Infant; Sucking Behavior

Outcome Measures

Primary Outcomes (6)

• The time to transition to oral feeding (hours)

  It was measured when the preterm infant swiched from gavage feeding to oral feeding.

  up to three weeks

• Time to discharge (hours)

  It was measured at discharge

  up to 2 months

• The sucking success (First measurement)

  The sucking success was assessed using the LATCH Breastfeeding Assessment Tool. The tool was developed by Jensen et al. (1994) and adapted to Turkish by Yenal and Okumus (2003). It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother's nipple type; C (Comfort, breast/nipple), the mother's level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0 to 2. The total score ranges from 0 to 10, with high scores indicating successful sucking.

  at the beginning of the study, up to three weeks

• The sucking success (Second measurement)

  The sucking success was assessed using the LATCH Breastfeeding Assessment Tool. The tool was developed by Jensen et al. (1994) and adapted to Turkish by Yenal and Okumus (2003). It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother's nipple type; C (Comfort, breast/nipple), the mother's level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0 to 2. The total score ranges from 0 to 10, with high scores indicating successful sucking.

  48 hours after the second measurement of sucking success

• The sucking success (Last measurement)

  The sucking success was assessed using the LATCH Breastfeeding Assessment Tool. The tool was developed by Jensen et al. (1994) and adapted to Turkish by Yenal and Okumus (2003). It consists of five evaluation criteria: L (Latch on breast), how well the infant latches onto the breast; A (Audible swallowing), the amount of audible swallowing noted; T (Type of nipple), the mother's nipple type; C (Comfort, breast/nipple), the mother's level of comfort in relation to the nipple; and H (Hold/Help), the amount of help the mother needs to hold her infant to the breast. Each item is rated on a scale of 0 to 2. The total score ranges from 0 to 10, with high scores indicating successful sucking.

  through study completion, an average of 2 months

• The time to transition to exclusive breastfeeding (hours)

  It was measured when the preterm infant transitioned to exclusive breastfeeding

  up to two weeks

Study Arms (2)

Experimental

EXPERIMENTAL

The experimental group participants were breastfed for ten minutes (five minutes for each breast) every day from the day they started oral feeding until they switched to exclusive breastfeeding. The nurse placed the warmed breast milk or formula in SNS. She then fixed it to the mother's nipples. Each experimental group participant sucked on the two breasts for 15 minutes. Breastfeeding (ten minutes), resting and SNS preparation (five minutes), and SNS feeding (15 minutes) were limited to a total of 30 minutes in light of earlier research.

Device: MEDELA Supplemental nursing system

Control

NO INTERVENTION

Preterm infants were fed according to the clinical feeding protocol. They were not SNS-fed.

Interventions

MEDELA Supplemental nursing system DEVICE

The experimental group participants were fed based on the MEDELA Supplemental Nursing System, which consists of a syringe/container and a feeding catheter. One end of the feeding probe is in the syringe/container, while the other is fixed to the mother's nipple through a plaster. MEDELA SNS is a sterile product with an adjustable breast milk flow system and neck strap. It is bisphenol A (BPA) free. All its parts are in direct contact with breast milk. This system allows the baby to both suck and feed (MEDELA Supplemental Nursing System, 2018).

Experimental

Eligibility Criteria

• Age: 30 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• being between the gestational ages of 30 to 34 weeks
• having a birthweight of ≥1000 g
• having an APGAR score of \>6
• having stabilized for 48 hours after receiving mechanical ventilator or continuous positive air pressure or both
• being exclusively gavage-fed with breast and/or formula and ready to switch to oral feeding
• being willing to breastfeed

You may not qualify if:

• having a congenital malformation that may cause asphyxia and affect breathing
• having an intraventricular hemorrhage, intracranial hemorrhage, or periventricular leukomalacia
• having intestinal anomalies or hyperbilirubinemia requiring exchange transfusion
• having respiratory distress syndrome, bronchopulmonary dysplasia, or other chronic lung diseases.

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

Location

Related Publications (5)

• Kaya V, Aytekin A. Effects of pacifier use on transition to full breastfeeding and sucking skills in preterm infants: a randomised controlled trial. J Clin Nurs. 2017 Jul;26(13-14):2055-2063. doi: 10.1111/jocn.13617. Epub 2017 Mar 21.

  PMID: 27754572 RESULT

• Penny F, Judge M, Brownell E, McGrath JM. What Is the Evidence for Use of a Supplemental Feeding Tube Device as an Alternative Supplemental Feeding Method for Breastfed Infants? Adv Neonatal Care. 2018 Feb;18(1):31-37. doi: 10.1097/ANC.0000000000000446.

  PMID: 29373347 RESULT

• Penny F, Judge M, Brownell EA, McGrath JM. International Board Certified Lactation Consultants' Practices Regarding Supplemental Feeding Methods for Breastfed Infants. J Hum Lact. 2019 Nov;35(4):683-694. doi: 10.1177/0890334419835744. Epub 2019 Apr 19.

  PMID: 31002761 RESULT

• 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 RESULT

• Calikusu Incekar M, Caglar S, Kaya Narter F, Tercan Tarakci E, Ozpinar E, Demirci Ecevit E. An alternative supplemental feeding method for preterm infants: the supplemental feeding tube device. Turk J Med Sci. 2021 Aug 30;51(4):2087-2094. doi: 10.3906/sag-2009-323.

  PMID: 33992038 RESULT

MeSH Terms

Conditions

Breast Feeding; Premature Birth; Sucking Behavior

Condition Hierarchy (Ancestors)

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

Study Officials

• Aynur Aytekin Özdemir, PhD

  Istanbul Medeniyet University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants were randomized into the experimental and control groups using a block randomization method. Research shows that gestational age and sucking experience affect the sucking behavior of preterm infants (Kaya and Aytekin, 2017; Yildiz and Arikan, 2012). Therefore, gestational age (30-32 and 33-34 weeks), gender (girls and boys), and LATCH scores (0-2, 3-6, and 7-10 points) were used for block randomization. The blocks were repeated three times in each group. Thirty-six participants were assigned to each group. A 2X2X3X3 blocked randomization list was developed using an online randomization tool (Sealed Envelope Ltd, 2018).

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 18, 2023
• Study Start: November 20, 2018
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)