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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01817062

Acronym

NeoNec

Enrollment

Registered

2013-03-22

Start date

2001-01-31

Completion date

2013-03-31

Last updated

2013-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Very Low Birth Weight

Keywords

Capillary leakage, Acute Abdomen, Low birth weight

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?

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 4 Weeks

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results