Impact of oral application of Gastrografin on the meconium evacuation in very low birth weight infants

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000851-33-AT

Enrollment

104

Registered

2008-04-15

Start date

2008-04-28

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Evacuation of inspissated meconium in very low birth weight infants (infants with a birthweight below 1500 grams)

Interventions

Trade Name: Gastrografin Product Name: Gastrografin Product Code: Gastrografin Pharmaceutical Form: Gastroenteral suspension INN or Proposed INN: Gastrografin Pharmaceutical form of the placebo: Gastr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: inborn very low birth weight infants with abirthweight below 1500 grams and a gestational age below 32 weeks Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: complex dysmorphic syndromes congenital abnormalities of the GI-tract severe haemodynamic instability

Design outcomes

Primary

Measure	Time frame
Main Objective: accelerate meconium evacuation in very low birth weight infants;Secondary Objective: impact of the procedure on introduction of enteral feedings- shorter time on full enteral feedings;Primary end point(s): time to appearence of last meconium in days	—

Countries

Austria

Outcome results

None listed

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