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

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

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?

Study Overview

• Status: Completed
• Conditions: Very Low Birth Weight

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - University Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 4 weeks (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Neonates; Neonates with very low birth weight and surgery therapy of acute abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Capillary Leakage	Postoperative Capillary Leakage (defined as weight gain within 48 hours or development of oedema within 48 hours)	48 hours from Baseline (Operation)

Secondary Outcome Measures

Outcome Measure	Time Frame
Mortality	Up to 1 year
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimate): March 22, 2013

Study Record Updates

• Last Update Posted (Estimate): May 8, 2013
• Last Update Submitted That Met QC Criteria: May 7, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Low birth weight; Capillary leakage; Acute Abdomen
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Body Weight; Birth Weight; Abdomen, Acute
• Other Study ID Numbers: NeoNec