BreastfeedingNCT05087043
Effects of Oral Stimulation and Supplemental Nursing System
A study testing Oral motor stimulation (OMS) and The supplemental nursing system (SNS) in people with Breastfeeding, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. Read more about this study
- Who is it for?
- Ages 1 day to 30 days
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Oral motor stimulation (OMS) and The supplemental nursing system (SNS)
- 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
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2018to 15 Jun 2018
- 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 1 day to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- a birth weight of 1,000 gr and above,
- a gestational age between 30 and 34 weeks,
- no congenital anomaly,
- no severe asphyxia or chronic lung disease,
- spontaneous breathing,
- grades III and IV intracranial hemorrhage and no periventricular leukomalacia
Who cannot join
- congenital anomaly
- grades III and IV intracranial hemorrhage and periventricular leukomalacia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants
This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.
Read the detailed description
This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.
- Conditions
- Breastfeeding
- Being tested
- Oral motor stimulation (OMS) and The supplemental nursing system (SNS)
- Keywords
- Preterm, oral stimulation, supplemental nursing system
- Medical subject headings
- Breast Feeding, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral motor stimulation (OMS) and The supplemental nursing system (SNS)Device
OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster.
| Study group | Role | What they receive |
|---|---|---|
| Oral Stimulation and Supplemental Nursing System group | Experimental | Oral motor Stimulation (OMS) and an Supplemental Nursing System (SNS) were applied to preterm infants in the experimental group. Receives: Device: Oral motor stimulation (OMS) and The supplemental nursing system (SNS) |
| control group | No intervention | The clinic's routine feeding protocol was applied to the babies in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
transition times to oral feeding
Transition time to oral feeding is the time that the preterm baby outgrew gavage feeding and fed with complementary nutritional support, and it was evaluated as days in the study.
Measured: up to three weeks
transition times to full breast
The transition time to full breastfeeding is the duration from the day that the preterm baby started oral nutrition until the day they started breastfeeding
Measured: up to 15 days
the weight of the babies when they started oral nutrition
. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
Measured: up to three weeks
the weight of the babies when they started full breastfeeding
The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone
Measured: up to 15 days
the duration of the baby's discharge
The duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge
Measured: up to 2 months
The oral nutrition body weight
The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
Measured: up to three weeks
The full breastfeeding body weight
The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone.
Measured: up to 15 days
The discharge body weight
The discharge body weight is the weight in grams of preterm babies at discharge
Measured: up to 2 months
The sucking success
The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.
Measured: In the first month after discharge
Secondary outcomes (3)
Heart rate of the babies
Heart rate
Measured: 15 minutes
respiratory rate of the babies
respiratory rate
Measured: 15 minutes
oxygen saturation of the babies
oxygen saturation
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2021
- Study start1 Feb 2018
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Karayagiz Muslu, Muğla Sıtkı Koçman University
- Investigators
- gonca muslu, Study chair, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05087043
- Sponsor's protocol ID
- 1
- Status last verified
- Oct 2021
- First submitted
- 15 Sep 2021
- Last updated
- 21 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Stimulation and Supplemental Nursing System on the Transition Time to Full Breast of Mother and Sucking Success in Preterm Infants
- ClinicalTrials.gov ID
- NCT05087043
- Acronym / sponsor ID
- 1
- Conditions
- Breastfeeding
- Keywords
- Preterm, oral stimulation, supplemental nursing system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 21 Oct 2021 (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.
This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants.
Detailed description
This study aimed to investigate the effect of oral stimulation and a supplemental nursing system on the time to full maternal breastfeeding and sucking success in preterm infants. The sample consisted of 70 preterm babies. Oral motor stimulation and a supplemental nursing system were applied to the preterm infants in the experimental group, while no intervention was applied to those in the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Stimulation and Supplemental Nursing System group | Experimental | Device: Oral motor stimulation (OMS) and The supplemental nursing system (SNS)Oral motor Stimulation (OMS) and an Supplemental Nursing System (SNS) were applied to preterm infants in the experimental group. |
| control group | No intervention | –The clinic's routine feeding protocol was applied to the babies in the control group. |
Who may qualify
- Ages
- 1 day to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- a birth weight of 1,000 gr and above,
- a gestational age between 30 and 34 weeks,
- no congenital anomaly,
- no severe asphyxia or chronic lung disease,
- spontaneous breathing,
Key exclusion criteria (2 listed)
- congenital anomaly
- grades III and IV intracranial hemorrhage and periventricular leukomalacia
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 |
|---|---|---|
| Oral motor stimulation (OMS) and The supplemental nursing system (SNS)OMS and an SNS were applied to preterm infants in the experimental group. Oral stimulation intervention provides assisted movement to activate muscle contraction and provides movement against resistance to build strength. The cheeks (internal and external), lips, gums, tongue, and palate were stimulated by finger-stroking following the protocol. OMS consisted of intra (oral region) and peri-oral stimulation (around the oral region). The OMS was administered three times a day by a nurse, from the day of initiation of oral feeding to the day of independent oral feeding 15 minutes before the feeding schedule. A bottle/container was filled with breast milk before the process and given to the baby via SNS while the baby was holding the mother's breast. The SNS consists of a syringe/container and a feeding catheter. One end of the feeding probe is inside the syringe/container, while the other end of it is fixed to the mother's nipple using plaster. | Device | Oral Stimulation and Supplemental Nursing System group |
Primary outcome
transition times to oral feeding
Time frame: up to three weeks
Transition time to oral feeding is the time that the preterm baby outgrew gavage feeding and fed with complementary nutritional support, and it was evaluated as days in the study.
transition times to full breast
Time frame: up to 15 days
The transition time to full breastfeeding is the duration from the day that the preterm baby started oral nutrition until the day they started breastfeeding
the weight of the babies when they started oral nutrition
Time frame: up to three weeks
. The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
the weight of the babies when they started full breastfeeding
Time frame: up to 15 days
The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone
the duration of the baby's discharge
Time frame: up to 2 months
The duration of discharge is the number of days between the admission of preterm babies to intensive care and their discharge
The oral nutrition body weight
Time frame: up to three weeks
The oral nutrition body weight is the weight of preterm babies when they started oral nutrition after gavage.
The full breastfeeding body weight
Time frame: up to 15 days
The full breastfeeding body weight is the weight in grams of preterm babies when they started feeding from the breast alone.
The discharge body weight
Time frame: up to 2 months
The discharge body weight is the weight in grams of preterm babies at discharge
The sucking success
Time frame: In the first month after discharge
The sucking score of preterm babies was determined using LATCH breastfeeding scores at discharge.
3 secondary outcomes
Heart rate of the babies
Time frame: 15 minutes
respiratory rate of the babies
Time frame: 15 minutes
oxygen saturation of the babies
Time frame: 15 minutes
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 21 Oct 2021.
- Individual participant dataSharing planned: No
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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.
gonca muslu study chair
Muğla Sıtkı Koçman 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 Oral motor stimulation (OMS) and The supplemental nursing system (SNS) in people with Breastfeeding, run by Muğla Sıtkı Koçman 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 2 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 21 Oct 2021. 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?
transition times to oral feeding (time frame: up to three weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2021.