About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
HAPTOS (Handling Adapted to Postnatal age with Tactile-kinaesthetic and Oral sensorimotor Stimulation
Procedure/SurgeryTactile-kinaesthetic and Oral sensorimotor Stimulation
Treatment groups
Trial outcomes
Primary outcomes
Number of days to achieve full enteral feeding
measuring the time from birth until enteral intake reaches 150ml/kg/d
Postmenstrual age at achievement of full oral feeding
Number of postmenstrual weeks until gastrointestinal tube is taken out
Secondary outcomes
First meconium passage
Postnatal day at first meconium
Duration of meconium passage
Number of days until normal defecation
Use of laxatives
Number of laxatives given
Gastrointestinal Motility
Volume of gastric residuals per week
Sponsors and contacts
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Radboud University Medical Center
Lead sponsor
Nutricia Research
Collaborator