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

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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?


Detailed Summary:
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome: Postoperative Capillary Leakage [ Time Frame: 48 hours from Baseline (Operation) ]

Postoperative Capillary Leakage (defined as weight gain within 48 hours or development of oedema within 48 hours)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Amount of transfusions during surgery [ Time Frame: Up to 5 hours ]
  • Re-surgery rate [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Length of stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 12 weeks ]
  • Mortality [ Time Frame: Up to 1 year ]


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: March 20, 2013
Date Started: January 2001
Date Completion:
Last Updated: May 7, 2013
Last Verified: May 2013