Improving gut function in high-risk newborns through sensory stimulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This intervention aims to assess the effectiveness of the HAPTOS method, which involves tactile-kinesthetic and oral sensorimotor stimulation, in enhancing gastrointestinal function in preterm infants born before 30 weeks of gestation and those with congenital diaphragmatic hernia. The study will compare outcomes between infants receiving standard care plus the HAPTOS intervention and those receiving only standard care. The primary focus is on the time taken to achieve full enteral and oral feeding, which is critical for the health and development of these vulnerable infants.

Why it matters

Who can join: the full rules

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

Where it's running

• Radboud University Nijmegen Medical Centre
  Nijmegen, Netherlands Recruiting

Study contacts

• Principal investigator: Viola Christmann, MD, PhD — Radboud University Medical Center
• Study coordinator: Yvet Kroeze
• Email: pediatricresearchunit@radboudumc.nl
• Phone: +31 (0)24 36 55 700

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.