Preterm Birth ComplicationNCT04751903
Feeding and Sucking in Preterm Infants
A study testing oral motor stimulation in people with Preterm Birth Complication and Breast Feeding, run by Bozok University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking. Read more about this study
- Who is it for?
- Ages 29 to 33 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth Complication, Breast Feeding
- What is being tested?
- oral motor stimulation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2017to 19 Mar 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 29 to 33 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Born between 29th and 34th gestational weeks, based on the mother's last menstruation date,
- Percentile measurements consistent with their gestational week measurements,
- Stable vital signs,
- APGAR scores between 4 and 10 in the 1st and 5th minutes,
- Stable for 48 hours after having received mechanical ventilation and/or continuous positive airway pressure,
- Being breastfed,
- Mother's eagerness to breastfeed the infant,
- Voluntary participation of parents in the study.
Who cannot join
- Suffered from severe asphyxia,
- Born with a low birth weight according to gestational week,
- Have intraventricular bleeding,
- With a congenital anomaly,
- Babies without their mother.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oral Motor Stimulation on Feeding and Sucking in Preterm Infants
This study aimed to determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking.
Read the detailed description
In recent years, with advances in methods of neonatal resuscitation and caring methods, the survival rate of preterm infants has gradually increased. Sucking, swallow and respiratory dysfunction are widespread complications in the preterm infants that reason oral feeding difficulties. Safe and successful oral feeding requires proper maturation of sucking, swallowing, and respiration. The development of behaviors necessary for safe and successful nutrition begins long before birth. Jaw movements begin to be seen in the intrauterine 11th week. But sucking-swallowing-respiratory coordination is not sufficiently developed before 34 weeks of gestation. For this reason, preterm babies at the greater gestational week usually show more developed and consistent feeding skills. Maternal breast milk is best for neurodevelopment in preterm infants. Achieve oral feeding and maternal breast milk as early as possible is beneficial for preterm infants.
Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants. Previous studies have indicated that the use of OMS during or before the transition to oral feeding may not only have positive effects on the preterm infants' feeding behaviors but also enhance their general clinical course. Preterm infants who suffer from oral feeding problems often experience longterm health problems and delayed discharge from the hospital. A more effective feeding decreases adverse outcomes by decreasing hospital stays.
Preterm infants are required to prolonged NICU stay in order to stabilized, feeding, and gain optimal weight. Increasing prematurity and reduced birth weight lead to extensive resource utilization. In addition all nutritional options except breast milk increase the cost. OMS can develop sucking success and provide early oral feeding. Thus nurse labor and hospital costs may decrease and OMS can be a cost-effective application.
,
- Conditions
- Preterm Birth Complication, Breast Feeding
- Being tested
- oral motor stimulation
- Keywords
- Feeding, Sucking success, Oral motor stimulation, Preterm infant
- 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 stimulationBehavioural
Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions.It took 15 minutes to apply the OMS by lightly touching their cheeks, lips, gums, and tongue with fingertips for the first 12 minutes, followed by letting the infant suck on a pacifier for the remaining 3 minutes. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants.
| Study group | Role | What they receive |
|---|---|---|
| Oral motor stimulation | Experimental | After the infants were assessed by a neonatologist, Oral motor stimulation was administered to the experimental group thrice a day (at 9:00, 12:00, 15:00 hours) for 15 minutes right before feeding, over a 14-day period. Receives: Behavioral: oral motor stimulation |
| Control group | No intervention | The preterm infant' the control group were only fed by the researcher thrice a day (at 9:00, 12:00, 15:00 hours) over a 14-day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Assessment Tool
It was developed by Jensen, Wallace, \& Kelsay (1994). Demirhan (1997) conducted its Turkey validity test and revealed that it is a reliable and easy-to-use scale. Each criterion is rated in the point range of 0-2 points. Breastfeeding is then assessed based on the sum of these scores. The highest and lowest scores of the tool are 10 and 0, respectively, and higher scores signify breastfeeding/sucking success.
Measured: 36th gestational week , 5 minute
body weight
The baby's body weight is weighed in grams with a digital scale.
Measured: 36th gestational week ,3 minute
length
The baby's length is measured in cm with a tape measure.
Measured: 36th gestational week,1 minute
head circumference
The baby's head circumference is measured in cm with a tape measure.
Measured: 36th gestational week ,1 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start5 May 2017
- Primary completion18 Aug 2017
- Study completion19 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Preterm Birth ComplicationStudies 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
- The study was conducted as the randomized controlled and double-blind experimental trial. This study was guided by the CONSORT checklist
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozok University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şenay ARAS DOĞAN, Bozok University
- Investigators
- Ayda ÇELEBİOĞLU, Prof., Principal investigator, Mersin UniversKadir Şerafettin TEKGÜNDÜZ, Assoc. Prof, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751903
- Sponsor's protocol ID
- 216S081
- Other IDs
- 216S081
- Status last verified
- Feb 2025
- First submitted
- 2 Feb 2021
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared after the article is published.
Publications
Aguilar-Rodriguez M, Leon-Castro JC, Alvarez-Cerezo M, Aledon-Andujar N, Escrig-Fernandez R, Rodriguez de Dios-Benlloch JL, Hervas-Marin D, Vento-Torres M. The Effectiveness of an Oral Sensorimotor Stimulation Protocol for the Early Achievement of Exclusive Oral Feeding in Premature Infants. A Randomized, Controlled Trial. Phys Occup Ther Pediatr. 2020;40(4):371-383. doi: 10.1080/01942638.2019.1698688. Epub 2019 Dec 9.
PubMed 31814522Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23.
PubMed 24461572Coker-Bolt P, Jarrard C, Woodard F, Merrill P. The effects of oral motor stimulation on feeding behaviors of infants born with univentricle anatomy. J Pediatr Nurs. 2013 Jan;28(1):64-71. doi: 10.1016/j.pedn.2012.03.024. Epub 2012 Apr 10.
PubMed 22497742Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.
PubMed 30851536
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Motor Stimulation on Feeding and Sucking in Preterm Infants
- ClinicalTrials.gov ID
- NCT04751903
- Acronym / sponsor ID
- 216S081
- Conditions
- Preterm Birth Complication, Breast Feeding
- Keywords
- Feeding, Sucking success, Oral motor stimulation, Preterm infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Bozok UniversityUniversity, hospital or other
- Study start
- 5 May 2017 (actual)
- Primary completion
- 18 Aug 2017 (actual)
- Study completion
- 19 Mar 2018 (actual)
- First posted
- 12 Feb 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 determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking.
Detailed description
In recent years, with advances in methods of neonatal resuscitation and caring methods, the survival rate of preterm infants has gradually increased. Sucking, swallow and respiratory dysfunction are widespread complications in the preterm infants that reason oral feeding difficulties. Safe and successful oral feeding requires proper maturation of sucking, swallowing, and respiration. The development of behaviors necessary for safe and successful nutrition begins long before birth. Jaw movements begin to be seen in the intrauterine 11th week. But sucking-swallowing-respiratory coordination is not sufficiently developed before 34 weeks of gestation. For this reason, preterm babies at the greater gestational week usually show more developed and consistent feeding skills. Maternal breast milk is best for neurodevelopment in preterm infants. Achieve oral feeding and maternal breast milk as early as possible is beneficial for preterm infants.
Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants. Previous studies have indicated that the use of OMS during or before the transition to oral feeding may not only have positive effects on the preterm infants' feeding behaviors but also enhance their general clinical course. Preterm infants who suffer from oral feeding problems often experience longterm health problems and delayed discharge from the hospital. A more effective feeding decreases adverse outcomes by decreasing hospital stays.
Preterm infants are required to prolonged NICU stay in order to stabilized, feeding, and gain optimal weight. Increasing prematurity and reduced birth weight lead to extensive resource utilization. In addition all nutritional options except breast milk increase the cost. OMS can develop sucking success and provide early oral feeding. Thus nurse labor and hospital costs may decrease and OMS can be a cost-effective application.
,
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study was conducted as the randomized controlled and double-blind experimental trial. This study was guided by the CONSORT checklist
| Arm | Type | Receives |
|---|---|---|
| Oral motor stimulation | Experimental | Behavioral: oral motor stimulationAfter the infants were assessed by a neonatologist, Oral motor stimulation was administered to the experimental group thrice a day (at 9:00, 12:00, 15:00 hours) for 15 minutes right before feeding, over a 14-day period. |
| Control group | No intervention | –The preterm infant' the control group were only fed by the researcher thrice a day (at 9:00, 12:00, 15:00 hours) over a 14-day period. |
Who may qualify
- Ages
- 29 to 33 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Born between 29th and 34th gestational weeks, based on the mother's last menstruation date,
- Percentile measurements consistent with their gestational week measurements,
- Stable vital signs,
- APGAR scores between 4 and 10 in the 1st and 5th minutes,
- Stable for 48 hours after having received mechanical ventilation and/or continuous positive airway pressure,
Key exclusion criteria (5 listed)
- Suffered from severe asphyxia,
- Born with a low birth weight according to gestational week,
- Have intraventricular bleeding,
- With a congenital anomaly,
- Babies without their mother.
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 stimulationOral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions.It took 15 minutes to apply the OMS by lightly touching their cheeks, lips, gums, and tongue with fingertips for the first 12 minutes, followed by letting the infant suck on a pacifier for the remaining 3 minutes. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants. | Behavioural | Oral motor stimulation |
Primary outcome
LATCH Breastfeeding Assessment Tool
Time frame: 36th gestational week , 5 minute
It was developed by Jensen, Wallace, \& Kelsay (1994). Demirhan (1997) conducted its Turkey validity test and revealed that it is a reliable and easy-to-use scale. Each criterion is rated in the point range of 0-2 points. Breastfeeding is then assessed based on the sum of these scores. The highest and lowest scores of the tool are 10 and 0, respectively, and higher scores signify breastfeeding/sucking success.
body weight
Time frame: 36th gestational week ,3 minute
The baby's body weight is weighed in grams with a digital scale.
length
Time frame: 36th gestational week,1 minute
The baby's length is measured in cm with a tape measure.
head circumference
Time frame: 36th gestational week ,1 minute
The baby's head circumference is measured in cm with a tape measure.
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 Feb 2025.
- Background: PubMed 31814522Aguilar-Rodriguez M, Leon-Castro JC, Alvarez-Cerezo M, Aledon-Andujar N, Escrig-Fernandez R, Rodriguez de Dios-Benlloch JL, Hervas-Marin D, Vento-Torres M. The Effectiveness of an Oral Sensorimotor Stimulation Protocol for the Early Achievement of Exclusive Oral Feeding in Premature Infants. A Randomized, Controlled Trial. Phys Occup Ther Pediatr. 2020;40(4):371-383. doi: 10.1080/01942638.2019.1698688. Epub 2019 Dec 9.
- Background: PubMed 24461572Bache M, Pizon E, Jacobs J, Vaillant M, Lecomte A. Effects of pre-feeding oral stimulation on oral feeding in preterm infants: a randomized clinical trial. Early Hum Dev. 2014 Mar;90(3):125-9. doi: 10.1016/j.earlhumdev.2013.12.011. Epub 2014 Jan 23.
- Background: PubMed 22497742Coker-Bolt P, Jarrard C, Woodard F, Merrill P. The effects of oral motor stimulation on feeding behaviors of infants born with univentricle anatomy. J Pediatr Nurs. 2013 Jan;28(1):64-71. doi: 10.1016/j.pedn.2012.03.024. Epub 2012 Apr 10.
- Background: PubMed 30851536Ghomi H, Yadegari F, Soleimani F, Knoll BL, Noroozi M, Mazouri A. The effects of premature infant oral motor intervention (PIOMI) on oral feeding of preterm infants: A randomized clinical trial. Int J Pediatr Otorhinolaryngol. 2019 May;120:202-209. doi: 10.1016/j.ijporl.2019.02.005. Epub 2019 Feb 5.
- Individual participant dataSharing planned: No. It will be shared after the article is published.
Related trials for Preterm Birth Complication
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Recruiting
The Periviable GOALS Decision Support Tool
Pregnancy Preterm, Premature Birth
Active, not recruitingPhase 4
Improving Neonatal Health Through Rapid Malaria Testing in Early Pregnancy With High-Sensitivity Diagnostics
Malaria,Falciparum, Malaria in Pregnancy
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
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.
Ayda ÇELEBİOĞLU, Prof. principal investigator
Mersin Univers
Kadir Şerafettin TEKGÜNDÜZ, Assoc. Prof principal investigator
Ataturk 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 in people with Preterm Birth Complication and Breast Feeding, run by Bozok 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 8 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 21 Feb 2025. 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?
LATCH Breastfeeding Assessment Tool (time frame: 36th gestational week , 5 minute). The study lists 4 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 NCT04751903, which also lists 4 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 21 Feb 2025.