Balanced Anesthesia for Intubation of Premature Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Stress on Performance of Neonatal Endotracheal Intubation

NCT02758704

Neonatal Intubation Performance

COMPLETED NA

Surfactant Administration by Insure or Thin Catheter

NCT04445571

RDS of Prematurity Surfactant Deficiency Syndrome Neonatal Analgesia

RECRUITING NA

Evaluation of the Neonatal Autonomic Stress During Intubations Under Propofol in a Population of Premature Infants Under 33 w'GA

NCT03721640

Hyaline Membrane Disease Preterm Infant

COMPLETED

ADMA and Mechanical Ventilation in Preterm Infants

NCT00460044

Premature Birth

COMPLETED

Randomized Trial of Nasal Continuous Positive Airway Pressure or Synchronized Nasal Ventilation in Premature Infants.

NCT00188968

Apnea Infant, Premature Bronchopulmonary Dysplasia

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Premature Birth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Premedication with atropine and morphine

Group Type ACTIVE_COMPARATOR

Tracheal intubation for respiratory care in preterm infants

Intervention Type PROCEDURE

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

2

Premedication with glycopyrronium, thiopental, suxamethonium and remifentanil

Group Type ACTIVE_COMPARATOR

Tracheal intubation for respiratory care in preterm infants

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tracheal intubation for respiratory care in preterm infants

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

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No