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

Retrospective Analysis of Intraoperative Volume Administration in Neonates Without Congenital Malformations With Very Low Birth Weight and Acute Abdomen.

Sponsors

Lead Sponsor: Charite University, Berlin, Germany

Source Charite University, Berlin, Germany
Brief 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?

Overall Status Completed
Start Date January 2001
Completion Date March 2013
Primary Completion Date December 2011
Study Type Observational
Primary Outcome
Measure Time Frame
Postoperative Capillary Leakage 48 hours from Baseline (Operation)
Secondary Outcome
Measure Time Frame
Amount of transfusions during surgery Up to 5 hours
Re-surgery rate Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Length of stay Participants will be followed for the duration of hospital stay, an expected average of 12 weeks
Mortality Up to 1 year
Enrollment 89
Condition
Eligibility

Sampling Method: Probability Sample

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 4 Weeks

Healthy Volunteers: No

Location
Facility: Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - University Berlin
Location Countries

Germany

Verification Date

May 2013

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Charite University, Berlin, Germany

Investigator Full Name: Claudia Spies

Investigator Title: Department of Anesthesiology and Intensive Care Medicine, CVK and CCM

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Neonates

Description: Neonates with very low birth weight and surgery therapy of acute abdomen

Acronym NeoNec
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov