Infant, PrematureNCT06308471
Effect of Baby Massage on Oral Motor Skills of Premature Babies
A study testing Baby massage was applied to the intervention group (n=20) of the study and Oral stimulation in people with Infant, Premature, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
This experimental research was conducted in a single-blind, block randomized controlled design type. The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature
- What is being tested?
- Baby massage was applied to the intervention group (n=20) of the study and Oral stimulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 1 May 2023
- 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 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Being between 28-33 weeks of gestation,
- Not having a congenital disease,
- Clinical findings are stable and normal,
- It meets the readiness criteria for oral feeding,
- Being fed at full dose via Oral/Nasogastric tube and having never attempted oral intake before,
- It must weigh between 1000-2000 grams
- Parents give their consent to participate in the research and record video.
Who cannot join
- Premature babies of parents who did not give consent to participate in the study,
- Premature babies of parents who gave up participating in the study at any stage of the study,
- Physiological stability was impaired during the data collection process; Premature babies who require oxygen support and/or mechanical respirators,
- Conditions that disrupt clinical stability such as intracranial bleeding, necrotizing enterocolitis, neonatal sepsis are included in the process.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Baby Massage on Oral Motor Coordination Ability in Premature Babies
This experimental research was conducted in a single-blind, block randomized controlled design type.
The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.
As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20).
Comparative results were evaluated statistically.
Read the detailed description
The Effect of Baby Massage on Oral Motor Coordination Ability in Prematures Purpose: The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.
Method: The research was a single-blind, block randomized controlled design type and data was collected between September 2021 and May 2023. Baby massage was applied to the intervention group (n=20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (n=20). The applications were applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale. Descriptive statistical methods, Fisher test, chi-square analysis, dependent and independent t test, Mann Whitney U test, one-way analysis of variance, Kruskal Wallis test, Pearson and Spearman correlations were used to evaluate the research results.
- Conditions
- Infant, Premature
- Being tested
- Baby massage was applied to the intervention group (n=20) of the study, Oral stimulation
- Keywords
- Oral feeding skills, Baby massage, Fucile 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.
Baby massage was applied to the intervention group (n=20) of the studyOther
The application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies.
Oral stimulationOther
The application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies.
| Study group | Role | What they receive |
|---|---|---|
| Group of baby massage | Experimental | Being between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams Receives: Other: Baby massage was applied to the intervention group (n=20) of the study |
| Group of oral stimulation (Fucile Protocol) | Experimental | Being between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams Receives: Other: Oral stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for first oral feeding
assessment of feeding skills
Measured: up to 36th week of gestation
time for full oral feeding
assessment of feeding skills
Measured: up to 38th week of gestation
Secondary outcomes (1)
discharge time
time to hospital discharge (related to feeding ability)
Measured: up to 40th week of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Sep 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Ege 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Baby massage was applied to the intervention group (20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (20).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazire Arat, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308471
- Sponsor's protocol ID
- ege üniversitesi
- Status last verified
- Mar 2024
- First submitted
- 15 Feb 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I want to think about sharing
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Baby Massage on Oral Motor Coordination Ability in Premature Babies
- ClinicalTrials.gov ID
- NCT06308471
- Acronym / sponsor ID
- ege üniversitesi
- Conditions
- Infant, Premature
- Keywords
- Oral feeding skills, Baby massage, Fucile protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 13 Mar 2024 (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 experimental research was conducted in a single-blind, block randomized controlled design type.
The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.
As a result of the power analysis, baby massage was applied to the intervention group (n = 20) and oral stimulation with the Fucile protocol was applied to the control group (n = 20).
Comparative results were evaluated statistically.
Detailed description
The Effect of Baby Massage on Oral Motor Coordination Ability in Prematures Purpose: The primary purpose of the study is to examine the effect of premature baby massage on oral motor coordination skills. The secondary aim is to evaluate the consistency of use of The Oral Feeding clinical scale in premature babies in Turkey.
Method: The research was a single-blind, block randomized controlled design type and data was collected between September 2021 and May 2023. Baby massage was applied to the intervention group (n=20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (n=20). The applications were applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale. Descriptive statistical methods, Fisher test, chi-square analysis, dependent and independent t test, Mann Whitney U test, one-way analysis of variance, Kruskal Wallis test, Pearson and Spearman correlations were used to evaluate the research results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Baby massage was applied to the intervention group (20) of the study, and oral stimulation was applied with the Fucile protocol to the control group (20).
| Arm | Type | Receives |
|---|---|---|
| Group of baby massage | Experimental | Other: Baby massage was applied to the intervention group (n=20) of the studyBeing between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams |
| Group of oral stimulation (Fucile Protocol) | Experimental | Other: Oral stimulationBeing between 28-33 weeks of gestation, Not having a congenital disease, Meeting the readiness criteria for oral feeding, Must be in the weight range of 1000-2000 grams |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Being between 28-33 weeks of gestation,
- Not having a congenital disease,
- Clinical findings are stable and normal,
- It meets the readiness criteria for oral feeding,
- Being fed at full dose via Oral/Nasogastric tube and having never attempted oral intake before,
Key exclusion criteria (4 listed)
- Premature babies of parents who did not give consent to participate in the study,
- Premature babies of parents who gave up participating in the study at any stage of the study,
- Physiological stability was impaired during the data collection process; Premature babies who require oxygen support and/or mechanical respirators,
- Conditions that disrupt clinical stability such as intracranial bleeding, necrotizing enterocolitis, neonatal sepsis are included in the process.
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 |
|---|---|---|
| Baby massage was applied to the intervention group (n=20) of the studyThe application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies. | Other | Group of baby massage |
| Oral stimulationThe application was applied for 15 minutes every day for ten days, and oral feeding trials were video recorded. Feeding videos were evaluated by expert neonatal nurses using The Oral Feeding Scale without knowing the application group of the babies. | Other | Group of oral stimulation (Fucile Protocol) |
Primary outcome
time for first oral feeding
Time frame: up to 36th week of gestation
assessment of feeding skills
time for full oral feeding
Time frame: up to 38th week of gestation
assessment of feeding skills
1 secondary outcome
discharge time
Time frame: up to 40th week of gestation
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 13 Mar 2024.
- Individual participant dataSharing planned: No. I want to think about sharing
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baby massage was applied to the intervention group (n=20) of the study and Oral stimulation in people with Infant, Premature, run by Ege 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 7 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 13 Mar 2024. 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?
time for first oral feeding (time frame: up to 36th week of gestation). The study lists 2 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 13 Mar 2024.