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Completed

NCT Number: NCT05815706

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

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

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Key information

Conditions

Breastfeeding Behavior Breast Feeding Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Preterm Infant Sucking Behavior Urogenital Diseases

Age range

30 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medeniyet University

Istanbul, Kadıköy, 34720, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Primary outcomes

  1. The time to transition to oral feeding (hours)

    Time frame: up to three weeks

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

  2. Time to discharge (hours)

    Time frame: up to 2 months

    It was measured at discharge

  3. The sucking success (First measurement)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: up to two weeks

    It was measured when the preterm infant transitioned to exclusive breastfeeding

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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