Balanced Anesthesia for Intubation of Premature Infants

Premature Birth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00216944
• Other study ID #: EUDRACT EU 2004-001583-52
• Status: Completed
• Phase: Phase 4
• First received: September 15, 2005
• Last updated: February 12, 2010
• Start date: August 2005
• Est. completion date: October 2009

Study information

• Verified date: December 2010
• Source: Lund University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth

Intervention

Procedure:
• Tracheal intubation for respiratory care in preterm infants
Premedication with atropine 0.02 mg/kg and morphine 0.03 mg/kg
• Tracheal intubation for respiratory care in preterm infants
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

Locations

Country	Name	City	State
Sweden	Neonatal Departement Lund University Hospital	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Lund University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Pain score at intubation		6-9 months	No
Secondary	Biochemical stress/pain response		6-9 months	No
Secondary	Physiological stress/pain response		6-9 months	No
Secondary	Behavioural stress/pain response		6-9 months	No
Secondary	Neurophysiological stress/pain response (aEEG)		6-9 months	No