Clinical trial NCT05815706: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Preterm Infant
Sucking Behavior
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 72
Sex: ALL
Minimum age (years): 30
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: The time to transition to oral feeding (hours)
timeFrame: up to three weeks
measure: Time to discharge (hours)
timeFrame: up to 2 months
measure: The sucking success (First measurement)
timeFrame: at the beginning of the study, up to three weeks
measure: The sucking success (Second measurement)
timeFrame: 48 hours after the second measurement of sucking success
measure: The sucking success (Last measurement)
timeFrame: through study completion, an average of 2 months
measure: The time to transition to exclusive breastfeeding (hours)
timeFrame: up to two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
state: Kadıköy
Study officials:
affiliation: Istanbul Medeniyet University
name: Aynur Aytekin Özdemir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.