Swallowing DisorderNCT05687708
Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia
A study testing Non-Nutritive Sucking in people with Swallowing Disorder and Perinatal Asphyxia, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the… Read more about this study
- Who is it for?
- Ages 34 to 41 monthsHealthy volunteers can take part
- Conditions the study is for
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn
- What is being tested?
- Non-Nutritive Sucking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2021to 25 Jul 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 34 to 41 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- to be diagnosed with asphyxia,
- to have received hypothermia treatment,
- to have started enteral nutrition,
- to have physiological stability to tolerate NNS stimulation.
Who cannot join
- Having a craniofacial anomaly,
- having a congenital anomaly,
- being referred to another center/hospital during treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Non-nutritive Sucking Stimulation on Oral Intake and Early Feeding Skills in Newborns With Perinatal Asphyxia: A Randomized Controlled Trial
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated.
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding.
Read more
The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly.
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.
Read the detailed description
Perinatal asphyxia is the interruption of fetal blood flow or gas exchange during the perinatal period. Injury to the brain as a result of systemic hypoxia caused by disruption of gas exchange and slowing of cerebral blood flow is called hypoxic ischemic encephalopathy (HIE). Perinatal asphyxia may be maternally related or may occur as a result of conditions related to the placenta and the newborn itself. It may have etiologies such as maternal diseases such as diabetes, hypertension or preeclampsia, uterine rupture, cord compression, congenital airway anomalies of the newborn, neurological disorder, and severe cardiopulmonary disease. According to the World Health Organization (WHO) report, perinatal asphyxia causes 4 million newborn deaths every year and constitutes 23% of total neonatal deaths. Asphyxia, which has effects such as death, seizures and HIE in the short term, has effects such as motor disorders such as cerebral palsy, sensory disorders such as vision and hearing loss, cognitive, neurodevelopmental, behavioral and emotional disorders in the long term. Malnutrition is a problem that can occur both in the short and long term. In the short term, it may have consequences such as orogastric or nasogastric tube feeding due to sucking and/or swallowing dysfunction, prolonged feeding times in the long term, frequent coughing, aspiration pneumonia and gastrostomy. The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated.
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding.
The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The NNS stimulation method applied in a newborn with severe asphyxia with medical complications was investigated in a case study and it was pointed out that it could have positive results, but more research should be done in this patient group.
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.
- Conditions
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood, Hypoxic-Ischemic Encephalopathy, Speech Therapy
- Being tested
- Non-Nutritive Sucking
- Keywords
- perinatal asphyxia, non-nutritive sucking, oral feeding, oral stimulation
- Medical subject headings
- Deglutition Disorders, Hypoxia-Ischemia, Brain, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Nutritive SuckingOther
NNS is stimulated by giving stimulus into the baby's mouth with the help of a finger wearing gloves.
| Study group | Role | What they receive |
|---|---|---|
| Non-Nutritive Sucking | Experimental | Non-Nutritive Sucking Receives: Other: Non-Nutritive Sucking |
| Control | No intervention | routine treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Feeding Skills Assessment Tool
are the scores obtained by the clinician from the early feeding assessment tool. The minimum score that can be obtained from the scale is 19, and the maximum score is 57. A higher score indicates better feeding skills.
Measured: 1 month
Time from tube feeding to oral intake
how many days the baby transitions from tube feeding to oral intake
Measured: 20 days
Secondary outcomes (2)
discharge time
how many days the baby is discharged from the neonatal intensive care unit
Measured: 1 month
weight gain
is the weight information of the baby at certain intervals
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start1 Nov 2021
- Primary completion20 May 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Swallowing DisorderStudies of the same condition, open and under way.
- More trials run by Medipol 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hilal Berber Çiftci, Medipol University
- Investigators
- Seyhun Topbas, Study chair, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687708
- Sponsor's protocol ID
- MedipolDKT
- Status last verified
- Oct 2023
- First submitted
- 8 Jan 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harding C, Frank L, Dungu C, Colton N. The use of nonnutritive sucking to facilitate oral feeding in a term infant: a single case study. J Pediatr Nurs. 2012 Dec;27(6):700-6. doi: 10.1016/j.pedn.2012.01.006. Epub 2012 Feb 22.
PubMed 22366642
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-nutritive Sucking Stimulation on Oral Intake and Early Feeding Skills in Newborns With Perinatal Asphyxia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05687708
- Acronym / sponsor ID
- MedipolDKT
- Conditions
- Swallowing Disorder, Perinatal Asphyxia, Feeding; Difficult, Newborn, Feeding Disorder of Infancy or Early Childhood, Hypoxic-Ischemic Encephalopathy, Speech Therapy
- Keywords
- perinatal asphyxia, non-nutritive sucking, oral feeding, oral stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 18 Jan 2023 (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.
The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated.
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding.
The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly.
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.
Detailed description
Perinatal asphyxia is the interruption of fetal blood flow or gas exchange during the perinatal period. Injury to the brain as a result of systemic hypoxia caused by disruption of gas exchange and slowing of cerebral blood flow is called hypoxic ischemic encephalopathy (HIE). Perinatal asphyxia may be maternally related or may occur as a result of conditions related to the placenta and the newborn itself. It may have etiologies such as maternal diseases such as diabetes, hypertension or preeclampsia, uterine rupture, cord compression, congenital airway anomalies of the newborn, neurological disorder, and severe cardiopulmonary disease. According to the World Health Organization (WHO) report, perinatal asphyxia causes 4 million newborn deaths every year and constitutes 23% of total neonatal deaths. Asphyxia, which has effects such as death, seizures and HIE in the short term, has effects such as motor disorders such as cerebral palsy, sensory disorders such as vision and hearing loss, cognitive, neurodevelopmental, behavioral and emotional disorders in the long term. Malnutrition is a problem that can occur both in the short and long term. In the short term, it may have consequences such as orogastric or nasogastric tube feeding due to sucking and/or swallowing dysfunction, prolonged feeding times in the long term, frequent coughing, aspiration pneumonia and gastrostomy. The transition period to full oral feeding in infants with perinatal asphyxia is important in predicting long-term outcomes. The transition to independent oral feeding is accepted as a discharge criterion by the American Academy of Pediatrics, and the long transition from tube feeding to oral feeding prolongs the discharge process. Prolonged transition to oral feeding increases maternal stress as it delays gastrointestinal problems, mother-infant interaction and attachment, as well as increasing health expenditures. Due to long-term feeding tube use; Infection, leakage, delay in wound healing, trauma caused by repeated placement, as well as oral reluctance are observed. In asphyxia infants, in whom oral-motor dysfunction is common, the transition to oral feeding takes a long time and tube feeding support is required. The effect of hypothermia, which is a general therapeutic intervention that reduces the risk of mortality and morbidity in infants with asphyxia, on oral feeding has been previously studied and shown to have a positive effect. They also found that MR imaging in infants with asphyxia and the need for gastrostomy and tube feeding in those with brainstem involvement were associated.
Various interventions that affect the transition to oral nutrition positively and shorten the discharge time are included in the literature. Stimulation of non-nutritive sucking (NNS) is the most frequently preferred method among these interventions. It has been shown in studies that there are no short-term negative effects of NNS stimulation with the help of a pacifier or gloved finger, and some clinical benefits such as better bottle feeding performance, acceleration of discharge and transition to oral feeding.
The effect of the NNS stimulation method, which has been shown to be effective in preterm infants with large-scale randomized controlled studies, is not known exactly. The NNS stimulation method applied in a newborn with severe asphyxia with medical complications was investigated in a case study and it was pointed out that it could have positive results, but more research should be done in this patient group.
The aim of this study is to examine the effect of NNS stimulation applied to oral feeding, feeding skills, weight gain and discharge in asphyxia infants receiving hypothermia treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Nutritive Sucking | Experimental | Other: Non-Nutritive SuckingNon-Nutritive Sucking |
| Control | No intervention | –routine treatment |
Who may qualify
- Ages
- 34 to 41 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- to be diagnosed with asphyxia,
- to have received hypothermia treatment,
- to have started enteral nutrition,
- to have physiological stability to tolerate NNS stimulation.
Key exclusion criteria (3 listed)
- Having a craniofacial anomaly,
- having a congenital anomaly,
- being referred to another center/hospital during treatment.
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 |
|---|---|---|
| Non-Nutritive SuckingNNS is stimulated by giving stimulus into the baby's mouth with the help of a finger wearing gloves. | Other | Non-Nutritive Sucking |
Primary outcome
Early Feeding Skills Assessment Tool
Time frame: 1 month
are the scores obtained by the clinician from the early feeding assessment tool. The minimum score that can be obtained from the scale is 19, and the maximum score is 57. A higher score indicates better feeding skills.
Time from tube feeding to oral intake
Time frame: 20 days
how many days the baby transitions from tube feeding to oral intake
2 secondary outcomes
discharge time
Time frame: 1 month
weight gain
Time frame: 1 month
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 6 Oct 2023.
- Background: PubMed 22366642Harding C, Frank L, Dungu C, Colton N. The use of nonnutritive sucking to facilitate oral feeding in a term infant: a single case study. J Pediatr Nurs. 2012 Dec;27(6):700-6. doi: 10.1016/j.pedn.2012.01.006. Epub 2012 Feb 22.
- 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.
Seyhun Topbas study chair
Medipol 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 Non-Nutritive Sucking in people with Swallowing Disorder and Perinatal Asphyxia, run by Medipol 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 4 inclusion and 3 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 6 Oct 2023. 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?
Early Feeding Skills Assessment Tool (time frame: 1 month). 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?
On the ClinicalTrials.gov record for NCT05687708, which also lists 1 linked publication.
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 6 Oct 2023.