Balanced Anesthesia for Intubation of Premature Infants

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00216944

Enrollment

Registered

2005-09-22

Start date

2005-08-31

Completion date

2009-10-31

Last updated

2010-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

Keywords

Intubation, premedication

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.

Interventions

PROCEDURETracheal intubation for respiratory care in preterm infants

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026