NCT05687708

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

Completed NA Last updated 6 October 2023

What this trial tests

NA trial testing Non-Nutritive Sucking in Swallowing Disorder in 100 participants. Completed in 25 July 2023.

Timeline

1 November 2021

Primary endpoint
20 May 2023

25 July 2023

Quick facts

Lead sponsor	Medipol University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	100
Start date	1 November 2021
Primary completion	20 May 2023
Estimated completion	25 July 2023
Sites	1 location across Turkey (Türkiye)

Drugs / interventions tested

• Non-Nutritive Sucking

Conditions studied

• Swallowing Disorder — all drugs for Swallowing Disorder →
• Perinatal Asphyxia — all drugs for Perinatal Asphyxia →
• Feeding; Difficult, Newborn — all drugs for Feeding; Difficult, Newborn →
• Feeding Disorder of Infancy or Early Childhood — all drugs for Feeding Disorder of Infancy or Early Childhood →

Sponsor

Medipol University

Who can join

Adults 34 Months to 41 Months, any sex, with Swallowing Disorder or Perinatal Asphyxia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Advances in Therapies to Treat Neonatal Hypoxic-Ischemic Encephalopathy.
   Ranjan AK, Gulati A. · · 2023 · cited 41× · PMID 37892791 · DOI 10.3390/jcm12206653