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Balanced Anesthesia for Intubation of Premature Infants

Primary Purpose

Premature Birth

Status

Completed

Phase

Phase 4

Locations

Sweden

Study Type

Interventional

Intervention

Tracheal intubation for respiratory care in preterm infants

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Intubation, premedication

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Neonatal Departement Lund University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Premedication with atropine and morphine

Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain score at intubation

Biochemical stress/pain response

Physiological stress/pain response

Behavioural stress/pain response

Neurophysiological stress/pain response (aEEG)

Full Information

NCT ID

NCT00216944

First Posted

September 15, 2005

Last Updated

February 12, 2010

Sponsor

Lund University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00216944

Brief Title

Balanced Anesthesia for Intubation of Premature Infants

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Lund University Hospital

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Premature Birth

Keywords

Intubation, premedication

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Premedication with atropine and morphine

Arm Title

Arm Type

Active Comparator

Arm Description

Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil

Intervention Type

Procedure

Intervention Name(s)

Tracheal intubation for respiratory care in preterm infants

Intervention Description

Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg

Intervention Type

Procedure

Intervention Name(s)

Tracheal intubation for respiratory care in preterm infants

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Pain score at intubation

Time Frame

6-9 months

Title

Biochemical stress/pain response

Time Frame

6-9 months

Title

Physiological stress/pain response

Time Frame

6-9 months

Title

Behavioural stress/pain response

Time Frame

6-9 months

Title

Neurophysiological stress/pain response (aEEG)

Time Frame

6-9 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vineta Fellman, Professor

Organizational Affiliation

Lund University and Lund University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Neonatal Departement Lund University Hospital

City

Lund

ZIP/Postal Code

221 85

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

23128421

Citation

Norman E, Wikstrom S, Rosen I, Fellman V, Hellstrom-Westas L. Premedication for intubation with morphine causes prolonged depression of electrocortical background activity in preterm infants. Pediatr Res. 2013 Jan;73(1):87-94. doi: 10.1038/pr.2012.153. Epub 2012 Nov 5.

Results Reference

derived

PubMed Identifier

21798556

Citation

Norman E, Wikstrom S, Hellstrom-Westas L, Turpeinen U, Hamalainen E, Fellman V. Rapid sequence induction is superior to morphine for intubation of preterm infants: a randomized controlled trial. J Pediatr. 2011 Dec;159(6):893-9.e1. doi: 10.1016/j.jpeds.2011.06.003. Epub 2011 Jul 27.

Results Reference

derived

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Balanced Anesthesia for Intubation of Premature Infants

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