BreastfeedingNCT05815706

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

A study testing MEDELA Supplemental nursing system in people with Breastfeeding and Preterm Infant, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 30 to 34 weeksHealthy volunteers can take part
Conditions the study is for: Breastfeeding, Preterm Infant, Sucking Behavior
What is being tested?: MEDELA Supplemental nursing system
Type of treatment: Pill or oral medicine, Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Nov 2018to 30 Apr 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 to 34 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Istanbul Medeniyet University
Istanbul, Kadıköy, 34720

Other trials in Turkey (Türkiye)

About this study

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

Read the 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.

Conditions: Breastfeeding, Preterm Infant, Sucking Behavior
Being tested: MEDELA Supplemental nursing system
Medical subject headings: Breast Feeding, Premature Birth, Sucking Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MEDELA Supplemental nursing systemDevice
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).

Study groups in NCT05815706
Study group	Role	What they receive
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. Receives: Device: MEDELA Supplemental nursing system
Control	No intervention	Preterm infants were fed according to the clinical feeding protocol. They were not SNS-fed.

What is being measured

The primary outcome is the main question the study is designed to answer.

The time to transition to oral feeding (hours)
It was measured when the preterm infant swiched from gavage feeding to oral feeding.
Measured: up to three weeks
Time to discharge (hours)
It was measured at discharge
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201830 Apr 2019

First posted18 Apr 2023
Study start20 Nov 2018
Primary completion30 Apr 2019
Study completion30 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for BreastfeedingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
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: Single blind
Who is masked: Investigator
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05815706
Sponsor's protocol ID: 2018-1/20
Status last verified: Apr 2023
First submitted: 23 Mar 2023
Last updated: 18 Apr 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: It will be shared after the article is published.

Publications

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.
PubMed 27754572
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.
PubMed 29373347
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.
PubMed 31002761
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.
PubMed 34784787
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.
PubMed 33992038

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding

All Breastfeeding trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05815706
Acronym / sponsor ID: 2018-1/20
Conditions: Breastfeeding, Preterm Infant, Sucking Behavior
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Istanbul Medeniyet UniversityUniversity, hospital or other
Study start: 20 Nov 2018 (actual)
Primary completion: 30 Apr 2019 (actual)
Study completion: 30 Apr 2019 (actual)
First posted: 18 Apr 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2
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).

Arm	Type	Receives
Experimental	Experimental	Device: MEDELA Supplemental nursing systemThe 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.
Control	No intervention	–Preterm infants were fed according to the clinical feeding protocol. They were not SNS-fed.

Who may qualify

Ages: 30 to 34 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MEDELA Supplemental nursing systemThe 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).	Device	Experimental

Primary outcome

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.
Time to discharge (hours)
Time frame: up to 2 months
It was measured at discharge
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.
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.
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.
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
Results publication: PubMed 27754572Kaya 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 publication: PubMed 29373347Penny 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 publication: PubMed 31002761Penny 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 publication: PubMed 34784787Celik 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 publication: PubMed 33992038Calikusu 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.
Individual participant dataSharing planned: No. It will be shared after the article is published.

Related trials for Breastfeeding

RecruitingObservational study
Improving Nutrition for Babies Born by Caesarean Section
Breastfeeding Mothers of Legal Age, Their Babies Under 6 Months Old Born Vaginally
RecruitingPhase 4
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
Lactation, Inflammatory Bowel Disease
Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aynur Aytekin Özdemir, PhD principal investigator

Istanbul Medeniyet University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MEDELA Supplemental nursing system in people with Breastfeeding and Preterm Infant, run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The time to transition to oral feeding (hours) (time frame: up to three weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05815706, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.