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Completed

NCT Number: NCT00216944

Balanced Anesthesia for Intubation of Premature Infants

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.

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Key information

Conditions

Premature Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Neonatal Departement Lund University Hospital

Lund, 221 85, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tracheal intubation for respiratory care in preterm infants

Procedure

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

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

    Time frame: 6-9 months

Secondary outcomes

  1. Pain score at intubation

    Time frame: 6-9 months

  2. Biochemical stress/pain response

    Time frame: 6-9 months

  3. Physiological stress/pain response

    Time frame: 6-9 months

  4. Behavioural stress/pain response

    Time frame: 6-9 months

  5. Neurophysiological stress/pain response (aEEG)

    Time frame: 6-9 months

Sponsors and collaborators

Lead sponsor

Lund University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Sep 22, 2005
Registry last updated
Feb 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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