Balanced Anesthesia for Intubation of Premature Infants

February 12, 2010 updated by: Lund University Hospital

Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study

The study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. In addition a pain scale for prolonged stress/pain for premature neonates in NICU-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. The hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Lund, Sweden, 221 85
        • Neonatal Departement Lund University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • <37 gw at birth
  • <72 hours postnatal age, not previously intubated and no analgetics or sedatives the last 12 hours or >72 hours postnatal age, primary or reintubation
  • Informed consent from parents

Exclusion Criteria:

  • Intubation directly postnatally at the delivery room
  • Asphyxia (apgar <4 at 10 min, Umb-pH <7,0
  • S-Potassium > 6,5
  • Major malformations
  • Postsurgery intubation
  • Included in an other intervention study first week in life
  • Other intervention study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Premedication with atropine and morphine
Procedure: Tracheal intubation for respiratory care in preterm infants
Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg
Procedure: Tracheal intubation for respiratory care in preterm infants
Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg
Active Comparator: 2
Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil
Procedure: Tracheal intubation for respiratory care in preterm infants
Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg
Procedure: Tracheal intubation for respiratory care in preterm infants
Premedication with glycopyrronium 0.005 mg/kg, thiopental 2-3 mg/kg (< 2 kg 2 mg/kg), suxamethonium 2 mg/kg and remifentanil 0.001 mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success of intubation according to a specific score including duration of the procedure and changes in oxygen saturation, blood pressure and heart rate during the intubation
Time Frame: 6-9 months
6-9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pain score at intubation
Time Frame: 6-9 months
6-9 months
Biochemical stress/pain response
Time Frame: 6-9 months
6-9 months
Physiological stress/pain response
Time Frame: 6-9 months
6-9 months
Behavioural stress/pain response
Time Frame: 6-9 months
6-9 months
Neurophysiological stress/pain response (aEEG)
Time Frame: 6-9 months
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: Vineta Fellman, Professor, Lund University and Lund University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 22, 2005

Study Record Updates

Last Update Posted (Estimate)

February 15, 2010

Last Update Submitted That Met QC Criteria

February 12, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EUDRACT EU 2004-001583-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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