Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this therapeutical intervention trial is to investigate whether tactile-kinesthaetic and oral sensorimotor stimulation can improve gastrointestional function in preterm infants born before gestational age of 30 weeks and newborns with congenital diaphragmatic hernia. The main question it aims to answer is: • To determine whether HAPTOS- intervention (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation) in the particpants results in earlier attainment (postnatal days) of full enteral feeding and/or full oral feeding (post menstrual age) compared to standard care. Researchers will compare an intervention group receiving standard of care plus HAPTOS intervention to a group of patients receiving only current standard of care.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 2 days
Healthy Volunteers: f
View:

• Preterm birth at gestational age \< 30 weeks or

• Diagnosis of Congenital Diaphragmatic Hernia

• Born at Amalia Children's Hospital or admitted 1rst day of life

• Written informed consent of both parents or representatives

Locations
Other Locations
Netherlands
Radboud University Nijmegen Medical Centre
RECRUITING
Nijmegen
Contact Information
Primary
Yvet Kroeze
pediatricresearchunit@radboudumc.nl
+31 (0)24 36 55 700
Backup
Viola Christmann, MD,PhD
viola.christmann@radboudumc.nl
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 200
Treatments
No_intervention: Standard care
Will receive standard of care according to the institutional protocol and principles of developmental care which currently belongs to (inter-) national guidelines and is regarded as safe.
Experimental: Standard care supplemented with HAPTOS intervention
Will receive standard of care according to the principles of developmental care which currently belongs to (inter-) national guidelines plus HAPTOS intervention which includes: tactile/ kinaesthetic massage of the trunk and extremities twice daily and stimulation of oral function by providing perioral stimulation up to 4 times a day. Interventions will be continued until clinical improvement.
Sponsors
Collaborators: Nutricia Research
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov