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CompletedNCT05687708Updated Oct 6, 2023

Effect of Non-nutritive Sucking on Transition to Oral Feeding in Infants With Asphyxia

An interventional study of Non-Nutritive Sucking in Swallowing Disorder, Perinatal Asphyxia and Feeding; Difficult, Newborn, sponsored by Medipol University. Completed at 1 site in Turkey. Open to participants aged 34 Months to 41 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-06.

Sponsored by Medipol University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Nov 2021, registered Jan 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
34 Months to 41 Months
Sex
All
01

Study 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 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.

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.

02

Conditions studied

  • 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
03

In context

Deglutition Disorders

871 studies on the registry are indexed under Deglutition Disorders; 237 are open to participants now.

This study's enrollment of 100 is above the median of 60 across 578 interventional studies indexed under Deglutition Disorders.

Browse Deglutition Disorders studies →

Lead sponsor

Medipol University is the lead sponsor of 326 studies on the registry; 88 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
34 Months to 41 Months
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • to be diagnosed with asphyxia,
  • to have received hypothermia treatment,
  • to have started enteral nutrition,
  • to have physiological stability to tolerate NNS stimulation.

Exclusion criteria

Exclusion Criteria:

  • Having a craniofacial anomaly,
  • having a congenital anomaly,
  • being referred to another center/hospital during treatment.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Non-Nutritive Sucking

    Non-Nutritive Sucking

    Other: Non-Nutritive Sucking

  • No intervention
    Control

    routine treatment

Interventions

  • OtherNon-Nutritive Sucking

    NNS is stimulated by giving stimulus into the baby's mouth with the help of a finger wearing gloves.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 month

  2. Time from tube feeding to oral intake

    how many days the baby transitions from tube feeding to oral intake

    Time frame: 20 days

Secondary outcomes

  1. discharge time

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

    Time frame: 1 month

  2. weight gain

    is the weight information of the baby at certain intervals

    Time frame: 1 month

07

Study locations

1 site
  • Medipol University
    Istanbul, Turkey
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05687708
Lead sponsor
Medipol University
Responsible party
Hilal Berber Çiftci (Doctoral Student, Speech and Language Therapist, Medipol University) — Principal investigator
First posted
Jan 18, 2023
Start date
Nov 1, 2021
Primary completion
May 20, 2023
Completion
Jul 25, 2023
Last update
Oct 6, 2023

Study contacts

Seyhun Topbas
study chair · Medipol University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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