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

Very Low Birth Weight Clinical Trial

— NeoNec  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817062
• Other study ID #: NeoNec
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: May 7, 2013
• Start date: January 2001
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: March 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 4 Weeks

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Abdomen, Acute
• Birth Weight
• Body Weight
• Very Low Birth Weight

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine, CCM and CVK, Charité - University Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Amount of transfusions during surgery		Up to 5 hours	No
Secondary	Re-surgery rate		Participants will be followed for the duration of hospital stay, an expected average of 12 weeks	No
Secondary	Length of stay		Participants will be followed for the duration of hospital stay, an expected average of 12 weeks	No
Secondary	Mortality		Up to 1 year	No