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

NCT06057415 | Recruiting

• 1 other identifier: 114536
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Feeding and Eating Disorders

Keywords

preterm infants; high-risk newborns; congenital diaphragmatic hernia; autonomous nervous system; tactile stimulation

Outcome Measures

Primary Outcomes (2)

• Number of days to achieve full enteral feeding

  measuring the time from birth until enteral intake reaches 150ml/kg/d

  60 days

• Postmenstrual age at achievement of full oral feeding

  Number of postmenstrual weeks until gastrointestinal tube is taken out

  52 weeks

Secondary Outcomes (13)

• First meconium passage

  14 days

• Duration of meconium passage

  14 days

• Use of laxatives

  60 days

• Gastrointestinal Motility

  100 days

• Vomiting

  duration of hospitalization up to 15 months

Study Arms (2)

Standard care

NO INTERVENTION

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.

Standard care supplemented with HAPTOS intervention

EXPERIMENTAL

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.

Procedure: HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation

Interventions

HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation PROCEDURE

Tactile-kinaesthetic and Oral sensorimotor Stimulation

Standard care supplemented with HAPTOS intervention

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Preterm infant born at gestational age ≥ 30 weeks
• Perinatal Asphyxia; (Apgar score at 5' \< 5 and first pH ≤ 7,0)
• Major congenital anomalies or birth defects other than congenital diaphragmatic hernia;
• Metabolic disease that necessitates a special diet other than human milk or formula feeding and or has a prognosis of impaired neurological development
• Parental refusal of participation

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Nutricia Research: collaborator

Study Sites (1)

Radboud University Nijmegen Medical Centre

Nijmegen, 6500 HB, Netherlands

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders; Hernias, Diaphragmatic, Congenital

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Diaphragmatic; Internal Hernia; Hernia; Pathological Conditions, Anatomical

Study Officials

• Viola Christmann, MD, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yvet Kroeze

CONTACT

+31 (0)24 36 55 700; pediatricresearchunit@radboudumc.nl

Viola Christmann, MD,PhD

CONTACT

viola.christmann@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The randomization will occur web-based, and will be protected from selection bias by using concealed, stratified and blocked randomization. The group of preterm infants will randomly be assigned to 2 treatment groups according to 6 strata. * Gestational age 24+0 - 26+0 weeks + Appropriate for gestational age (AGA) * Gestational age 24+0 - 26+0 weeks + Small for gestational age (SGA) * Gestational age 26+1 - 28+0 weeks + AGA * Gestational age 26+1 - 28+0 weeks + SGA * Gestational age 28+1 - 29+6 weeks + AGA * Gestational age 28+1 - 29+6 weeks + SGA

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: September 28, 2023
• Study Start: June 10, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2028
• Last Updated: August 27, 2024

Record last verified: 2024-06

Locations

NL (1)