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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 intubation

Biochemical 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

Page last updated: August 23, 2015

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