PretermNCT04946045
Feeding Readiness and Oral Feeding Success in Preterm Infants
A study testing Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) in people with Preterm and Feeding Behavior, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial summary
To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success. Read more about this study
- Who is it for?
- Ages 30 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm, Feeding Behavior, Enteral Feeding Intolerance
- What is being tested?
- Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jun 2021
- 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 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The mother's milk
- Preterm babies with a gestational age of 30-33 weeks
- No facial deformity,
- No respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding,
- No need for oxygen support,
- There will be preterm infants who are not fed orally, but who are started with tube (Orogastric) feeding.
Who cannot join
- Transferred to another center during the research,
- Unexpected complication development during the research,
- Occurrence of a pathology that will prevent or complicate oral feeding,
- In cases where there is no voluntary consent of the parent
- The mother is Covid positive
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Kınıklı Campus, 20160
About this study
Official title: The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study
To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.
Read the detailed description
The preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. However, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. This also means long hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital.
Many studies have been conducted on preterm infants on optimizing oral feeding performance. Studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. These sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods.
It has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding.
This thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.
- Conditions
- Preterm, Feeding Behavior, Enteral Feeding Intolerance
- Being tested
- Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)
- Keywords
- Preterm, Feeding Readiness, Oral feeding, sensorimotor intervention, neonatal nursing
- Medical subject headings
- Premature Birth, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)Other
Also called Supportive Care
Sensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the "Six-phase feeding progression protocol".
| Study group | Role | What they receive |
|---|---|---|
| İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group | Experimental | 1. Tactile/Kinesthetic Stimulation (15 min): It was applied 3 times a day, once every 3 hours for 10 days.
2. Nonnutritive Sucking: It was applied 8 times a day for 10 days with Orogastric (OG) feeding throughout the feeding. Receives: Other: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) |
| Control (Nonnutritive Sucking) Group | No intervention | 1) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral Feeding Readiness
Turkish version of the Preterm Oral Feeding Readiness Assessment Scale (T-POFRAS):It was administered to in preterm infants before and after 10 days of intervention by a neonatal nurse independent of the researcher.
Measured: 10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.
Secondary outcomes (1)
Oral Feeding Success
Six-phase feeding progression protocol
Measured: Change in oral feeding success level according to the 12-day six-phase feeding progression protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start1 Jun 2020
- Primary completion1 Jun 2020
- Study completion1 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PretermStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zühal Çamur, Pamukkale University
- Investigators
- Zühal Çamur, RN, PhD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946045
- Sponsor's protocol ID
- Preterm, Feeding Readiness
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 30 Jun 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 30 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sensorimotor Interventions on Feeding Readiness and Oral Feeding Success in Preterm Infants : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04946045
- Acronym / sponsor ID
- Preterm, Feeding Readiness
- Conditions
- Preterm, Feeding Behavior, Enteral Feeding Intolerance
- Keywords
- Preterm, Feeding Readiness, Oral feeding, sensorimotor intervention, neonatal nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 30 Jun 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.
To examine the effects of sensorimotor interventions applied to in preterm infants on readiness for feeding and oral feeding success.
Detailed description
The preterm neonate population cannot potentially be fed orally for a long time in the postnatal period. However, the inability of preterm infants to be fed orally as soon as they are born is not a disease, their adaptation to the external environment of the uterus is more complicated because their physiological functions are not yet mature. This also means long hospital stays for premature babies. Therefore, the American Academy of Pediatrics (AAP) has determined that oral feeding is one of the main criteria for the discharge of the preterm infant from the hospital.
Many studies have been conducted on preterm infants on optimizing oral feeding performance. Studies improve oral feeding skills of preterm infants by applying various sensorimotor interventions and cue-based feeding protocols to improve oral feeding performance. These sensorimotor interventions; non-nutritive sucking (pacifier), sucking-swallowing exercises, oral support, oral stimulation, tactile stimulation, kinesthetic stimulation, sound, smell, audio-visual stimulations, etc. methods were used alone or in combination with these methods.
It has been shown in studies that sensorimotor interventions increase the success of oral feeding in preterms, increase the daily feeding volume, increase weight gain, reduce the cost by shortening the hospital stay, shorten the transition time from gastric feeding to oral/breastfeeding and help mother-infant bonding.
This thesis study was conducted using evidence-based interventions that can facilitate the development of oral feeding skills in preterm infants, the feeding problems they encounter, and their transition from gastric feeding to oral feeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a randomized controlled study with a control group design with pre-test and post-test measurements from experimental research designs.
| Arm | Type | Receives |
|---|---|---|
| İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group | Experimental | Other: Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)1. Tactile/Kinesthetic Stimulation (15 min): It was applied 3 times a day, once every 3 hours for 10 days. 2. Nonnutritive Sucking: It was applied 8 times a day for 10 days with Orogastric (OG) feeding throughout the feeding. |
| Control (Nonnutritive Sucking) Group | No intervention | –1) Nonnutritive Sucking: Administered during feeding with Orogastric (OG) 8 times a day for 10 days. |
Who may qualify
- Ages
- 30 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The mother's milk
- Preterm babies with a gestational age of 30-33 weeks
- No facial deformity,
- No respiratory, cardiovascular, gastrointestinal and neurological disorders or syndromes that would prevent or complicate oral feeding,
- No need for oxygen support,
Key exclusion criteria (5 listed)
- Transferred to another center during the research,
- Unexpected complication development during the research,
- Occurrence of a pathology that will prevent or complicate oral feeding,
- In cases where there is no voluntary consent of the parent
- The mother is Covid positive
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 |
|---|---|---|
| Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)Also: Supportive CareSensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the "Six-phase feeding progression protocol". | Other | İntervention (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) Group |
Primary outcome
Oral Feeding Readiness
Time frame: 10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.
Turkish version of the Preterm Oral Feeding Readiness Assessment Scale (T-POFRAS):It was administered to in preterm infants before and after 10 days of intervention by a neonatal nurse independent of the researcher.
1 secondary outcome
Oral Feeding Success
Time frame: Change in oral feeding success level according to the 12-day six-phase feeding progression protocol
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 30 Jun 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.
Zühal Çamur, RN, PhD principal investigator
Pamukkale 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 Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking) in people with Preterm and Feeding Behavior, run by Pamukkale 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 5 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 30 Jun 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?
Oral Feeding Readiness (time frame: 10 days change in T-POFRAS (feeding readiness) after sensorimotor intervention.). 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 30 Jun 2021.