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

NCT01817062 | Completed

• 1 other identifier: NeoNec
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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?

Conditions

Very Low Birth Weight

Keywords

Capillary leakage; Acute Abdomen; Low birth weight

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (1)

Neonates

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

Eligibility Criteria

• Age: 1 Minute - 4 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• Birth weight \> 1500g

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Anesthesiology and Intensive Care Medicine, CVK and CCM

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: January 1, 2001
• Primary Completion: December 1, 2011
• Study Completion: March 1, 2013
• Last Updated: May 8, 2013

Record last verified: 2013-05

Locations

DE (1)