Feeding and Eating Disorders Clinical Trial
— NeoHemoHaptOfficial title:
Improving Gastrointestinal Function In High-Risk Newborns By Stimulation Of The Enteric Nervous System
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.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | May 31, 2028 |
Est. primary completion date | May 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 2 Days |
Eligibility | Inclusion Criteria: 1. Preterm birth at gestational age < 30 weeks or 2. Diagnosis of Congenital Diaphragmatic Hernia 3. Born at Amalia Children's Hospital or admitted 1rst day of life 4. Written informed consent of both parents or representatives Exclusion Criteria: 1. Preterm infant born at gestational age = 30 weeks 2. Perinatal Asphyxia; (Apgar score at 5' < 5 and first pH = 7,0) 3. Major congenital anomalies or birth defects other than congenital diaphragmatic hernia; 4. Metabolic disease that necessitates a special diet other than human milk or formula feeding and or has a prognosis of impaired neurological development 5. Parental refusal of participation |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Radboud University Medical Center | Nutricia Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days to achieve full enteral feeding | measuring the time from birth until enteral intake reaches 150ml/kg/d | 60 days | |
Primary | Postmenstrual age at achievement of full oral feeding | Number of postmenstrual weeks until gastrointestinal tube is taken out | 52 weeks | |
Secondary | First meconium passage | Postnatal day at first meconium | 14 days | |
Secondary | Duration of meconium passage | Number of days until normal defecation | 14 days | |
Secondary | Use of laxatives | Number of laxatives given | 60 days | |
Secondary | Gastrointestinal Motility | Volume of gastric residuals per week | 100 days | |
Secondary | Vomiting | Number of incidences of vomiting in combination with aspiration | duration of hospitalization up to 15 months | |
Secondary | Periodic breathing | Number of desaturations < 80% and/or bradycardia < 80/min that require intervention per week | duration of hospitalization up to 15 months | |
Secondary | Feeding difficulties | Number of infants with impaired oral motor skills | 24 months | |
Secondary | Maturation of heart rate variability | Number of infants with delayed regulation of the para- and sympathicus tonus measured continuously through monitordata collection | duration of intensive care stay up to 60 days | |
Secondary | Growth at postmenstrual age | Gain in weight, length, and head circumference including percentiles | at 40 weeks, 3, 6, 12, 18 and 24 weeks | |
Secondary | Morbidity | Number of infants with necrotizing enterocolitis, spsis, chronic lung disease, retinopathy of prematurity, intra-ventricular hemorrhage | 100 days | |
Secondary | Duration hospital stay | Postnatal age at time of discharge home | 100 days | |
Secondary | Neurocognitive development | Measuring cognitive and motor development using Bayley Scores of Infant Development (BSID III) | at 24 months | |
Secondary | Parent participation in care | Measuring number of parents who participate and frequency of activity | duration of hospitalization up to 100 days |
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