Balanced Anesthesia for Intubation of Premature Infants
Information source: Lund University Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Premature Birth
Intervention: Tracheal intubation for respiratory care in preterm infants (Procedure); Tracheal intubation for respiratory care in preterm infants (Procedure)
Phase: Phase 4
Status: Completed
Sponsored by: Lund University Hospital Official(s) and/or principal investigator(s): Vineta Fellman, Professor, Principal Investigator, Affiliation: Lund University and Lund University Hospital
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.
Clinical Details
Official title: Balanced Anesthesia for Intubation of Newborn Premature Infants - a Randomized Intervention Study
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: 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: Pain score at intubationBiochemical stress/pain response Physiological stress/pain response Behavioural stress/pain response Neurophysiological stress/pain response (aEEG)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Neonatal Departement Lund University Hospital, Lund 221 85, Sweden
Additional Information
Starting date: August 2005
Last updated: February 12, 2010
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