NCT00216944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

February 15, 2010

Status Verified

December 1, 2010

Enrollment Period

4.2 years

First QC Date

September 15, 2005

Last Update Submit

February 12, 2010

Conditions

Premature Birth

Keywords

Intubationpremedication

Outcome Measures

Primary Outcomes (1)

  • 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

    6-9 months

Secondary Outcomes (5)

  • Pain score at intubation

    6-9 months

  • Biochemical stress/pain response

    6-9 months

  • Physiological stress/pain response

    6-9 months

  • Behavioural stress/pain response

    6-9 months

  • Neurophysiological stress/pain response (aEEG)

    6-9 months

Study Arms (2)

1

ACTIVE COMPARATOR

Premedication with atropine and morphine

Procedure: Tracheal intubation for respiratory care in preterm infants

2

ACTIVE COMPARATOR

Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil

Procedure: Tracheal intubation for respiratory care in preterm infants

Interventions

Tracheal intubation for respiratory care in preterm infantsPROCEDURE

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

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \<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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neonatal Departement Lund University Hospital

Lund, 221 85, Sweden

Location

Related Publications (2)

  • 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.

    PMID: 23128421DERIVED

  • 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.

    PMID: 21798556DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Intubation, IntratrachealRespiratory Therapy

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsIntubationInvestigative Techniques

Study Officials

  • Vineta Fellman, Professor

    Lund University and Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

August 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

February 15, 2010

Record last verified: 2010-12

Locations

SE(1)