CompletedNot Applicable

Neonates With Very Low Birth Weight and Surgery Therapy of Acute Abdomen

Germany89 participantsStarted 2001-01

Plain-language summary

Objective: Due to high mortality rates the capillary leakage and the acute abdomen are important risk factors of the probability of survival. The aim of an optimal therapy of the acute abdomen within the neonatal period is beside the cure of the underlying disease the prophylaxis of capillary leakage with the help of optimised intra- and postoperative volume therapy. Question: Do the neonates with very low birth weight and a surgery therapy of acute abdomen benefit from early increase of the haemoglobin/haematocrit by optimised volume therapy with crystalloid and colloidal volume as prophylaxis of the capillary leakage?

Who can participate

Age range

1 Minute – 4 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria: * All Children with very low birth weight who have undergone surgery of acute abdomen within the neonatal period between 2001 and 2011 on "Campus Charité Mitte" or "Charité Virchow - Klinikum". * Neonates (calculated date of birth + 4 weeks) Exclusion criteria: * Birth weight \> 1500g

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Postoperative Capillary Leakage

Timeframe: 48 hours from Baseline (Operation)

Trial details

NCT IDNCT01817062

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2011-12

View on ClinicalTrials.gov More Very Low Birth Weight trials