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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).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

Turkey (Türkiye)1 site
  • Medipol University

    Istanbul

Other trials in Turkey (Türkiye)

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.

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 groups in NCT05687708
Study groupRoleWhat they receive
Non-Nutritive SuckingExperimentalNon-Nutritive Sucking
Receives: Other: Non-Nutritive Sucking
ControlNo interventionroutine treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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)
  1. discharge time

    how many days the baby is discharged from the neonatal intensive care unit

    Measured: 1 month

  2. 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.

  1. First posted18 Jan 2023
  2. Study start1 Nov 2021
  3. Primary completion20 May 2023
  4. Study completion25 Jul 2023

Resources

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)
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

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.

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