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Prospective, controlled intervention study to optimize bowel evacuation and stimulation in extremely premature infants

Prospective, controlled intervention study to optimize bowel evacuation and stimulation in extremely premature infants

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024191
Enrollment
54
Registered
2021-02-04
Start date
2020-09-01
Completion date
Unknown
Last updated
2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

P07.01 P07.02

Interventions

Group 1: Standard enema therapy at the time the study was designed Group 2: Rectal enemas with the new gravity enema method.

Sponsors

Klinik für Neonatologie und allgemeine Pädiatrie Klinikum Kassel
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • Premature babies up to the 2nd LT = 28th week of pregnancy or 24h inpatient stay • No spontaneous meconium loss after 24 hours

Exclusion criteria

Exclusion criteria: • Missing declaration of consent from the legal guardian • Palliative care patients whose therapy has been discontinued • Premature babies with underlying syndromes (e.g. trisomy 13, 18 or 21) • Premature babies with proven passage disorders or atresia

Design outcomes

Primary

MeasureTime frame
Incidence of intestinal complications: Intestinal perforation, necrotizing enterocolitis, meconium plug syndrome

Secondary

MeasureTime frame
• Duration of parenteral nutrition (h) • Number and amount of gastric remains [frequency and ml / day] • Weight development (increase / decrease in g / week)

Countries

Germany

Contacts

Public ContactAndreas Jenke

Klinik für Neonatologie und allgemeine Pädiatrie Klinikum Kassel

andreas.jenke@gnh.net+49 (0) 561 9805502

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026