Feeding; Difficult, NewbornNCT04945967
A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
A study testing New Method and Conventional Method in people with Feeding; Difficult, Newborn and Premature, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring respiratory support and those experiencing delays in beginning oral feeding are most often… Read more about this study
- Who is it for?
- Ages 28 to 34 weeks
- Conditions the study is for
- Feeding; Difficult, Newborn, Premature
- What is being tested?
- New Method and Conventional Method
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteIndonesia
- Study dates
- 13 Aug 2021to 26 Nov 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 28 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature infants born 28 to 34 weeks of gestational age
- Has achieved oral feeding readiness in the form of :
- Stable cardiorespiratory status
- Fully feed through orogastric tube of 120ml/kg/day without vomiting or bloating
- Strong and rhythmic non-nutritive sucking (NNS), measured objectively using sucking mechanism evaluation system (5 to 10 non-nutritive sucks per burst, the repetitive pattern was stable, with a pause of 4 to 9 seconds, and the amplitude was -16.7 to -87 mmHg)
- Parent/guardian give consent to participate
Who cannot join
- Craniomaxillofacial malformation
- Neonatal asphyxia with 5-minute APGAR score is less than 7
- Grade 3 and 4 intraventricular hemorrhage
- Using endotracheal tube at the time of assessment
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Cipto Mangunkusumo National General Hospital
Jakarta Pusat, DKI Jakarta, 1358
About this study
Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring respiratory support and those experiencing delays in beginning oral feeding are most often affected.
Majority of premature infants have poorly developed suck and swallow mechanisms. The neurological immaturity, abnormal muscle tone, depressed oral reflexes, and difficulty in regulating state, can decrease the quality of infant's oral motor skills and the quantity of intake. For these reasons many high-risk infants are unable to tolerate oral feeding from birth and have difficulty making the transition from tube feedings to functional oral feeding. This transition to full oral feeding is an important competency for the infant to attain prior to discharge home. Delays in discharge are often secondary to feeding difficulties, leading to increased medical costs.
Read more
Currently a number of treatment strategies exist to facilitate oral feeding in premature infants. These include environmental/physical modifications such as eliminating external stimuli during feedings, using therapeutic nipples to manipulate flow rate, positioning and swaddling to support the motor system and improve flexion, and oral motor intervention including Non-nutritive sucking (NNS) stimulation and oral/perioral stimulation. There are known various methods of oral and perioral stimulations. Recent study claimed that oral stimulations combined with non-nutritive sucking stimulation in premature infants for at least 10 days period could facilitate oral feeding ability.
The therapy of new method intervention that will be studied in this research was a combination of physiological flexion in therapeutic positioning with specific swaddling techniques, oral stimulation, stimulation of synergistic movements, and stimulation of non-nutritive sucking using a special designed pacifier according to the size of premature infant's oral cavity.
The objective of this study is to determine the time span required for premature infant to achieve safe and efficient oral feeding after new method intervention. Therefore, this new method expectedly can be used as an intervention to improve oral feeding ability in premature infant.
Read the detailed description
This study was designed as a double-blinded and randomized controlled trial, which was held from August 2021 until November 2021 in five tertiary hospitals in Jakarta area: Dr. Cipto Mangunkusumo National Central General Hospital, Harapan Kita Women \& Children's Hospital, Bunda Women \& Children's Hospital, Pasar Rebo Regional General Hospital, and Budi Kemuliaan General Hospital. Premature infants born in 28-34 weeks who has achieved oral feeding readiness but had not achieved oral feeding ability will be recruited as participants. Subjects were then randomized and assigned to New method and Conventional method intervention groups. The total number of sample size was 70 subjects.
Both interventions were given once a day, 30 minutes before the infant's feeding schedule. After each session of intervention was done, participant will be evaluated for oral feeding ability.
Participant will be in semi-upright position, using peristaltic plus for low-birth-weight pacifier in SS size. The volume of fluids feed will be decided based on neonatologist's assessment. Participant was stated to achieve oral feeding ability if participant was able to swallow more than 30% of the volume set by the neonatologist for the first 5 minutes at a rate of more than or equal to 1.5 ml / minute and without signs of aspiration. If the results of the evaluation show that the participant has not been able to achieve safe and efficient oral feeding, intervention will be terminated. If the participant has not fulfilled the criteria, intervention will be continued. However, if the participant became unstable after given each intervention, then intervention will be halted and will be repeated again in the next feeding schedule. After 3 consecutive trials and the participant is still unstable while given intervention, then the participant will be put in drop out category.
Statistical analysis will be conducted using SPSS ver. 20.0. The level of significance was set at <0.05. Interim analysis will be conducted in this research and will be done in three steps:
- Basic data analysis for comparing distribution between two intervention groups with descriptive analysis.
- Bivariate analysis using chi-square.
- Multivariate analysis using logistic regression if there are incomparable basic data variables.
- Conditions
- Feeding; Difficult, Newborn, Premature
- Being tested
- New Method, Conventional Method
- Keywords
- Premature Infant, Oral Feeding Ability, Therapeutic Positioning, Oromotor Intervention
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New MethodProcedure or surgery
Physiological flexion in therapeutic positioning, oral stimulation, stimulation of synergistic movements, and stimulation for non-nutritive sucking by using special designed pacifier for premature infant.
Conventional MethodProcedure or surgery
Oral stimulation and non-nutritive sucking stimulation using usual pacifier.
| Study group | Role | What they receive |
|---|---|---|
| New Method | Experimental | This intervention will be given once a day, 30 minutes before feeding schedule based on the neonatologist. Each session of intervention will take time about 18 minutes. Receives: Procedure: New Method |
| Conventional Method | Active comparator | This intervention will be given once a day, 30 minutes before feeding schedule based on the neonatologist. Each session of intervention will take time about 15 minutes. Receives: Procedure: Conventional Method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time Span to Achieve Safe and Efficient Oral Feeding After New Method Intervention
Time span is measured in days. New method intervention will be given once a day. After New method intervention is done, participant will be evaluated for safe and efficient oral feeding. If the participant has already fulfilled the criteria in safe and efficient oral feeding, intervention will be ended. If participant has not fulfilled the criteria, intervention will be continued.
Measured: 1st day after the first session of New method intervention to oral feeding ability achievement
Time Span to Achieve Safe and Efficient Oral Feeding After Conventional Method Intervention
Time span is measured in days. Conventional method intervention will be given once a day. After conventional method intervention is done, participant will be evaluated for safe and efficient oral feeding. If the participant has already fulfilled the criteria in safe and efficient oral feeding, intervention will be ended. If participant has not fulfilled the criteria, intervention will be continued.
Measured: 1st day after the first session of conventional method intervention to oral feeding ability achievement
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 start13 Aug 2021
- Primary completion26 Nov 2021
- Study completion26 Nov 2021
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 Universitas IndonesiaThe 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
- Model description
- Premature infants at 28 to 34 weeks of gestational age and has achieved oral feeding readiness but unable to achieve safe and efficient oral feeding will be divided into 2 groups for intervention: New method and conventional method interventions.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dr. Luh Karunia Wahyuni, Sp.KFR(K), Universitas Indonesia
- Investigators
- Luh K. Wahyuni, MD, Principal investigator, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945967
- Sponsor's protocol ID
- 21-03-0235
- Status last verified
- Jan 2022
- First submitted
- 28 May 2021
- Last updated
- 26 Jan 2022
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Intervention Method to Enhance Oral Feeding Ability in Premature Infants: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04945967
- Acronym / sponsor ID
- 21-03-0235
- Conditions
- Feeding; Difficult, Newborn, Premature
- Keywords
- Premature Infant, Oral Feeding Ability, Therapeutic Positioning, Oromotor Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 26 Nov 2021 (actual)
- Study completion
- 26 Nov 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.
Indonesia is the fifth country with the highest number of premature infants in the world. Research has shown that as many as 40% to 70% of premature infants exhibit both immature and atypical feeding skills and those requiring respiratory support and those experiencing delays in beginning oral feeding are most often affected.
Majority of premature infants have poorly developed suck and swallow mechanisms. The neurological immaturity, abnormal muscle tone, depressed oral reflexes, and difficulty in regulating state, can decrease the quality of infant's oral motor skills and the quantity of intake. For these reasons many high-risk infants are unable to tolerate oral feeding from birth and have difficulty making the transition from tube feedings to functional oral feeding. This transition to full oral feeding is an important competency for the infant to attain prior to discharge home. Delays in discharge are often secondary to feeding difficulties, leading to increased medical costs.
Currently a number of treatment strategies exist to facilitate oral feeding in premature infants. These include environmental/physical modifications such as eliminating external stimuli during feedings, using therapeutic nipples to manipulate flow rate, positioning and swaddling to support the motor system and improve flexion, and oral motor intervention including Non-nutritive sucking (NNS) stimulation and oral/perioral stimulation. There are known various methods of oral and perioral stimulations. Recent study claimed that oral stimulations combined with non-nutritive sucking stimulation in premature infants for at least 10 days period could facilitate oral feeding ability.
The therapy of new method intervention that will be studied in this research was a combination of physiological flexion in therapeutic positioning with specific swaddling techniques, oral stimulation, stimulation of synergistic movements, and stimulation of non-nutritive sucking using a special designed pacifier according to the size of premature infant's oral cavity.
The objective of this study is to determine the time span required for premature infant to achieve safe and efficient oral feeding after new method intervention. Therefore, this new method expectedly can be used as an intervention to improve oral feeding ability in premature infant.
Detailed description
This study was designed as a double-blinded and randomized controlled trial, which was held from August 2021 until November 2021 in five tertiary hospitals in Jakarta area: Dr. Cipto Mangunkusumo National Central General Hospital, Harapan Kita Women \& Children's Hospital, Bunda Women \& Children's Hospital, Pasar Rebo Regional General Hospital, and Budi Kemuliaan General Hospital. Premature infants born in 28-34 weeks who has achieved oral feeding readiness but had not achieved oral feeding ability will be recruited as participants. Subjects were then randomized and assigned to New method and Conventional method intervention groups. The total number of sample size was 70 subjects.
Both interventions were given once a day, 30 minutes before the infant's feeding schedule. After each session of intervention was done, participant will be evaluated for oral feeding ability.
Participant will be in semi-upright position, using peristaltic plus for low-birth-weight pacifier in SS size. The volume of fluids feed will be decided based on neonatologist's assessment. Participant was stated to achieve oral feeding ability if participant was able to swallow more than 30% of the volume set by the neonatologist for the first 5 minutes at a rate of more than or equal to 1.5 ml / minute and without signs of aspiration. If the results of the evaluation show that the participant has not been able to achieve safe and efficient oral feeding, intervention will be terminated. If the participant has not fulfilled the criteria, intervention will be continued. However, if the participant became unstable after given each intervention, then intervention will be halted and will be repeated again in the next feeding schedule. After 3 consecutive trials and the participant is still unstable while given intervention, then the participant will be put in drop out category.
Statistical analysis will be conducted using SPSS ver. 20.0. The level of significance was set at <0.05. Interim analysis will be conducted in this research and will be done in three steps:
- Basic data analysis for comparing distribution between two intervention groups with descriptive analysis.
- Bivariate analysis using chi-square.
- Multivariate analysis using logistic regression if there are incomparable basic data variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Premature infants at 28 to 34 weeks of gestational age and has achieved oral feeding readiness but unable to achieve safe and efficient oral feeding will be divided into 2 groups for intervention: New method and conventional method interventions.
| Arm | Type | Receives |
|---|---|---|
| New Method | Experimental | Procedure: New MethodThis intervention will be given once a day, 30 minutes before feeding schedule based on the neonatologist. Each session of intervention will take time about 18 minutes. |
| Conventional Method | Active comparator | Procedure: Conventional MethodThis intervention will be given once a day, 30 minutes before feeding schedule based on the neonatologist. Each session of intervention will take time about 15 minutes. |
Who may qualify
- Ages
- 28 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Premature infants born 28 to 34 weeks of gestational age
- Has achieved oral feeding readiness in the form of :
- Parent/guardian give consent to participate
Key exclusion criteria (4 listed)
- Craniomaxillofacial malformation
- Neonatal asphyxia with 5-minute APGAR score is less than 7
- Grade 3 and 4 intraventricular hemorrhage
- Using endotracheal tube at the time of assessment
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 |
|---|---|---|
| New MethodPhysiological flexion in therapeutic positioning, oral stimulation, stimulation of synergistic movements, and stimulation for non-nutritive sucking by using special designed pacifier for premature infant. | Procedure or surgery | New Method |
| Conventional MethodOral stimulation and non-nutritive sucking stimulation using usual pacifier. | Procedure or surgery | Conventional Method |
Primary outcome
Time Span to Achieve Safe and Efficient Oral Feeding After New Method Intervention
Time frame: 1st day after the first session of New method intervention to oral feeding ability achievement
Time span is measured in days. New method intervention will be given once a day. After New method intervention is done, participant will be evaluated for safe and efficient oral feeding. If the participant has already fulfilled the criteria in safe and efficient oral feeding, intervention will be ended. If participant has not fulfilled the criteria, intervention will be continued.
Time Span to Achieve Safe and Efficient Oral Feeding After Conventional Method Intervention
Time frame: 1st day after the first session of conventional method intervention to oral feeding ability achievement
Time span is measured in days. Conventional method intervention will be given once a day. After conventional method intervention is done, participant will be evaluated for safe and efficient oral feeding. If the participant has already fulfilled the criteria in safe and efficient oral feeding, intervention will be ended. If participant has not fulfilled the criteria, intervention will be continued.
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 26 Jan 2022.
- 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.
Luh K. Wahyuni, MD principal investigator
Faculty of Medicine, University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Method and Conventional Method in people with Feeding; Difficult, Newborn and Premature, run by Universitas Indonesia at 1 site in Indonesia.
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 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 26 Jan 2022. 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 Indonesia. 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 Span to Achieve Safe and Efficient Oral Feeding After New Method Intervention (time frame: 1st day after the first session of New method intervention to oral feeding ability achievement). 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 26 Jan 2022.