Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning
Glucose FG
Prospective, Placebo-Controlled Blinded Clinical Trial to Study the Efficacy of Orally Administered Glucose 20% for Relieving Pain During Nasopharyngeal Suctioning in Preterm Infants > 1500g Under CPAP-Therapy
1 other identifier
interventional
40
1 country
1
Brief Summary
Nasopharyngeal suctioning is a painful procedure that often becomes necessary in the care of preterm infants under CPAP therapy several times a day. Since the use of analgetic and sedative drugs is accompanied with multiple side effects these are usually being avoided. Glucose 20% has been shown to have an analgesic effect when administered to preterm infants previous to some painful procedures (i.e blood sampling). In this clinical trial the efficacy of orally administered Glucose 20% for relieving the procedural pain of nasopharyngeal suctioning is tested. The investigators' study has a cross-over design and is to include 40 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2008
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 24, 2008
CompletedFirst Posted
Study publicly available on registry
September 26, 2008
CompletedStudy Start
First participant enrolled
October 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFebruary 25, 2009
February 1, 2009
1.2 years
September 24, 2008
February 24, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The PIPP-Score, a validated pain-score, is used to measure the patient's pain
during nasopharyngeal suctioning
Study Arms (2)
Glucose 20%
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning
Eligibility Criteria
You may qualify if:
- Preterm newborns (\>1500g birth weight) up to a gestational age of 36+6 weeks
- CPAP respiratory therapy
- Parents' given written consent
You may not qualify if:
- Diseases complicating neuromuscular evaluation.
- Drug abuse by the mother
- Administration of other analgetic or sedative drugs within the previous 48h.
- Participation in another interventional clinical trial within 4 weeks before the beginning of this trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Neonatology, Children's Hospital, University of Cologne
Cologne, 50672, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Huenseler, Dr med
Neonatology, Children's Hospital, University of Cologne
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 24, 2008
First Posted
September 26, 2008
Study Start
October 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2010
Last Updated
February 25, 2009
Record last verified: 2009-02