Evaluation of the effect of enemas with a lipid solution to mobilize meconium in preterm infants

Evaluation of the effect of enemas with a lipid solution to mobilize meconium in preterm infants - SMOF_V1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024021

Enrollment

400

Registered

2021-02-02

Start date

2021-02-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

P76 P78

Interventions

Group 1: Enemas with NaCl 0.9%, Tween, Babylax Group 2: Enemas with SMOF lipid solution

Eligibility

Sex/Gender

All

Age

0 Days to No maximum

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age < 28 0/7 SSW or < 32 0/7 SSW with concomitant hypotrophy (GG < 10th percentile) and treatment within the first 24 hours of life at the study site

Exclusion criteria

Exclusion criteria: Congenital gastrointestinal malformation, inborn errors of metabolism, pre-determined palliative care

Design outcomes

Primary

Measure	Time frame
Rate of intestinal perforations and before and after the introduction of lipid enemas	—

Secondary

Measure	Time frame
Time in days until full enteral feeds Time in days with a peripheral or central venous catheter for (partial) parenteral nutrition Number and composition of applied enemas Stool patterns in the first days of life Rate of necrotizing enterocolitis	—

Countries

Germany

Contacts

Public ContactMaximilian Groß

Universitätskinderklinik Tübingen

maximilian.gross@med.uni-tuebingen.de070712983781

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 21, 2026