Feeding; Difficult, NewbornNCT03371927
Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization
A study testing SINC Feeding Protocol in people with Feeding; Difficult, Newborn, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Feeding is one of the most common problems encountered by preterm infants. Besides, effective and safe feeding is one of the important discharge criteria. Feeding problems of premature infants lead to prolonged hospitalization and increased healthcare cost. Read more about this study
- Who is it for?
- Ages 24 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Feeding; Difficult, Newborn
- What is being tested?
- SINC Feeding Protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Feb 2018to 18 Jul 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 24 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Having been born between 24-33+6 weeks of gestational age 28-33+6 postmenstrual weeks Monitoring with the diagnosis of healthy preterm infants
Who cannot join
- Receiving mechanical ventilation
- Congenital anomalies
- Having a surgical operation
- Having serious health problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Selcuk University Medical Faculty Hospital
Konya, Selcuklu, 42250
About this study
Official title: Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization in Premature Infants: Randomized Controlled Study
Feeding is one of the most common problems encountered by preterm infants. Besides, effective and safe feeding is one of the important discharge criteria. Feeding problems of premature infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding protocol was developed based on evidence-based feeding protocol (such as cue-based, infant-driven feeding) and individualized developmental care.
The aim of the study is to determine the effect of the SINC feeding protocol on weight gain, transition to oral feeding and the length of hospitalization in premature infants according to traditional feeding method.
Randomized controlled study, including 30 infants of 28-33+6 weeks gestation receiving either Standard Feeding or SINC Feeding Protocol.
- Conditions
- Feeding; Difficult, Newborn
- Being tested
- SINC Feeding Protocol
- Keywords
- Premature Infants, SINC feeding protocol
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SINC Feeding ProtocolOther
Safe individualized nipple-feeding competence protocol for premature infants
| Study group | Role | What they receive |
|---|---|---|
| Standard Feeding Method | No intervention | The control group consisted of prescribed volumes of oral and/or gavage feedings at two or three hour intervals per feeding. |
| SINC Feeding Protocol | Experimental | Safe individualized nipple-feeding competence (SINC) protocol Receives: Other: SINC Feeding Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Gain
When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (gr) along their hospitalization.
Measured: from birth to discharge (average 15 weeks)
Secondary outcomes (1)
Transition to Oral Feeding
time (day) from gavage to full oral feeding
Measured: from birth to discharge (average 15 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start28 Feb 2018
- Primary completion1 Mar 2019
- Study completion18 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding; Difficult, NewbornStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Raziye Çelen, Selcuk University
- Investigators
- Raziye CELEN, PhD, Principal investigator, Selcuk UniversityFatma TAS ARSLAN, Ass.Prof., Study director, Selcuk UniversiyHanifi SOYLU, Prof, Study director, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371927
- Sponsor's protocol ID
- 12.10.2017/34
- Status last verified
- Aug 2019
- First submitted
- 30 Nov 2017
- Last updated
- 5 Aug 2019
- 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 5 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization in Premature Infants: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03371927
- Acronym / sponsor ID
- 12.10.2017/34
- Conditions
- Feeding; Difficult, Newborn
- Keywords
- Premature Infants, SINC feeding protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 18 Jul 2019 (actual)
- First posted
- 13 Dec 2017 (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.
Feeding is one of the most common problems encountered by preterm infants. Besides, effective and safe feeding is one of the important discharge criteria. Feeding problems of premature infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding protocol was developed based on evidence-based feeding protocol (such as cue-based, infant-driven feeding) and individualized developmental care.
The aim of the study is to determine the effect of the SINC feeding protocol on weight gain, transition to oral feeding and the length of hospitalization in premature infants according to traditional feeding method.
Randomized controlled study, including 30 infants of 28-33+6 weeks gestation receiving either Standard Feeding or SINC Feeding Protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Feeding Method | No intervention | –The control group consisted of prescribed volumes of oral and/or gavage feedings at two or three hour intervals per feeding. |
| SINC Feeding Protocol | Experimental | Other: SINC Feeding ProtocolSafe individualized nipple-feeding competence (SINC) protocol |
Who may qualify
- Ages
- 24 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Having been born between 24-33+6 weeks of gestational age 28-33+6 postmenstrual weeks Monitoring with the diagnosis of healthy preterm infants
Key exclusion criteria (4 listed)
- Receiving mechanical ventilation
- Congenital anomalies
- Having a surgical operation
- Having serious health problems
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 |
|---|---|---|
| SINC Feeding ProtocolSafe individualized nipple-feeding competence protocol for premature infants | Other | SINC Feeding Protocol |
Primary outcome
Weight Gain
Time frame: from birth to discharge (average 15 weeks)
When babies are discharged from the hospital, researchers look at the nursing evolution sheet, their weight gain (gr) along their hospitalization.
1 secondary outcome
Transition to Oral Feeding
Time frame: from birth to discharge (average 15 weeks)
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 5 Aug 2019.
- Individual participant dataSharing planned: No
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Feasibility of Aerodigestive Stimulation Therapy Trial
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Premature Infant Oral Motor Intervention vs. Pacifier for Oral Feeding Transition in Preterm Infants
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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.
Raziye CELEN, PhD principal investigator
Selcuk University
Fatma TAS ARSLAN, Ass.Prof. study director
Selcuk Universiy
Hanifi SOYLU, Prof study director
Selcuk 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 SINC Feeding Protocol in people with Feeding; Difficult, Newborn, run by Selcuk 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 1 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 5 Aug 2019. 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?
Weight Gain (time frame: from birth to discharge (average 15 weeks)). 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 5 Aug 2019.