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

Primary Purpose

Breastfeeding, Preterm Infant, Sucking Behavior

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MEDELA Supplemental nursing system
Sponsored by
Istanbul Medeniyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breastfeeding

Eligibility Criteria

30 Weeks - 34 Weeks (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

  • Istanbul Medeniyet University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

The time to transition to oral feeding (hours)
It was measured when the preterm infant swiched from gavage feeding to oral feeding.
Time to discharge (hours)
It was measured at discharge
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.
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.
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.
The time to transition to exclusive breastfeeding (hours)
It was measured when the preterm infant transitioned to exclusive breastfeeding

Secondary Outcome Measures

Full Information

First Posted
March 23, 2023
Last Updated
April 4, 2023
Sponsor
Istanbul Medeniyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05815706
Brief Title
The Effect of the SNS-Based Feeding on Transition to Exclusive Breastfeeding in Preterm Infants
Official Title
The Effect of the Supplemental Nursing System-Based Feeding on Time to Transition to Exclusive Breastfeeding, Sucking Success, and Discharge Time: A Randomized Controlled Trial on Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Medeniyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
Nutrition is a critical problem in preterm infants. They should initially be enterally fed because they have poor sucking-swallowing-breathing coordination. Once a preterm infant develops that coordination, enteral feeding should be discontinued immediately. Then, the preterm should switch to oral feeding (breastmilk). However, preterm infants are not good at sucking because they get tired too quickly, have poor sucking skills, and lack enough experience. Therefore, we must use alternative supplemental feeding methods (bottle, spoon, dropper, cup, breastfeeding support system, and finger feeding) until preterm infants mature enough to meet their daily nutritional needs by breastfeeding alone (exclusive breastfeeding). The Supplemental Nursing System (SNS) is an alternative supplemental feeding method that supports the development of sucking skills while providing the preterm infant's nutritional needs. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breastfeeding, Preterm Infant, Sucking Behavior

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Preterm infants were fed according to the clinical feeding protocol. They were not SNS-fed.
Intervention Type
Device
Intervention Name(s)
MEDELA Supplemental nursing system
Intervention Description
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).
Primary Outcome Measure Information:
Title
The time to transition to oral feeding (hours)
Description
It was measured when the preterm infant swiched from gavage feeding to oral feeding.
Time Frame
up to three weeks
Title
Time to discharge (hours)
Description
It was measured at discharge
Time Frame
up to 2 months
Title
The sucking success (First measurement)
Description
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.
Time Frame
at the beginning of the study, up to three weeks
Title
The sucking success (Second measurement)
Description
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.
Time Frame
48 hours after the second measurement of sucking success
Title
The sucking success (Last measurement)
Description
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.
Time Frame
through study completion, an average of 2 months
Title
The time to transition to exclusive breastfeeding (hours)
Description
It was measured when the preterm infant transitioned to exclusive breastfeeding
Time Frame
up to two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Weeks
Maximum Age & Unit of Time
34 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aynur Aytekin Özdemir, PhD
Organizational Affiliation
Istanbul Medeniyet University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Medeniyet University
City
Istanbul
State/Province
Kadıköy
ZIP/Postal Code
34720
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
It will be shared after the article is published.
Citations:
PubMed Identifier
27754572
Citation
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.
Results Reference
result
PubMed Identifier
29373347
Citation
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.
Results Reference
result
PubMed Identifier
31002761
Citation
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.
Results Reference
result
PubMed Identifier
34784787
Citation
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.
Results Reference
result
PubMed Identifier
33992038
Citation
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.
Results Reference
result

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

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