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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorRadboud University Medical Center

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

    Tactile-kinaesthetic and Oral sensorimotor Stimulation

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: Standard care supplemented with HAPTOS interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of days to achieve full enteral feeding

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

Time frame
60 days
2

Postmenstrual age at achievement of full oral feeding

Number of postmenstrual weeks until gastrointestinal tube is taken out

Time frame
52 weeks

Secondary outcomes

1

First meconium passage

Postnatal day at first meconium

Time frame
14 days
2

Duration of meconium passage

Number of days until normal defecation

Time frame
14 days
3

Use of laxatives

Number of laxatives given

Time frame
60 days
4

Gastrointestinal Motility

Volume of gastric residuals per week

Time frame
100 days

Other outcomes

Sponsors and contacts

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