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

• Sponsor: Istanbul Medeniyet University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05815706
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site Per Month: 13.6

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Breastfeeding; Preterm Infant; Sucking Behavior	Device: MEDELA Supplemental nursing system	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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).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: Single (Investigator)
• Primary Purpose: Supportive Care
• 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
• Actual Study Start Date: Nov 20, 2018
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
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; 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).
No Intervention: Control Preterm infants were fed according to the clinical feeding protocol. They were not SNS-fed.

Outcome Measures

Primary Outcome Measures

1. The time to transition to oral feeding (hours) [up to three weeks]

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

2. Time to discharge (hours) [up to 2 months]

   It was measured at discharge

3. The sucking success (First measurement) [at the beginning of the study, up to three weeks]

   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.

4. The sucking success (Second measurement) [48 hours after the second measurement of sucking success]

   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.

5. The sucking success (Last measurement) [through study completion, an average of 2 months]

   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.

6. The time to transition to exclusive breastfeeding (hours) [up to two weeks]

   It was measured when the preterm infant transitioned to exclusive breastfeeding

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Weeks to 34 Weeks
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medeniyet University	Istanbul	Kadıköy	Turkey	34720

Sponsors and Collaborators

• Istanbul Medeniyet University

Investigators

• Principal Investigator: Aynur Aytekin Özdemir, PhD, Istanbul Medeniyet University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aynur Aytekin Ozdemir, Professor, Istanbul Medeniyet University
• ClinicalTrials.gov Identifier: NCT05815706
• Other Study ID Numbers: 2018-1/20
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premature Birth

Study Results

No Results Posted as of Apr 18, 2023