Analgesic Efficacy of Oral Glucose in Preterm Neonates Du... | NCT00761059

Studies
Analgesic Efficacy of Oral Glucose in Preterm Neonates During Suctioning

NCT00761059

Sponsor

University of Cologne

Status

Unknown status

Last Update Posted

Feb 25, 2009Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Analgesia

Interventions

Glucose 20%
Aqua

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Sep 24, 2008

First Submission Date that Met QC Criteria

Sep 25, 2008

First Posted Date

Sep 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2009

Last Update Posted Date

Feb 25, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glucose 20%	Active Comparator		Drug: Glucose 20%
placebo	Placebo Comparator		Drug: Aqua

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Glucose 20%	Drug	The oral application of 0,3 ml/kg Glucose 20% 3 minutes before nasopharyngeal suctioning	Glucose 20%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The PIPP-Score, a validated pain-score, is used to measure the patient's pain		during nasopharyngeal suctioning

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Preterm newborns (>1500g birth weight) up to a gestational age of 36+6 weeks
CPAP respiratory therapy
Parents' given written consent

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph Huenseler, Dr	Contact	0049-221-478-7190		christoph.huenseler@uni-koeln.de
Katharina Vezyroglou	Contact	0049-221-478-7190		katharina.vezyroglou@uk-koeln.de

Overall Officials

Name	Affiliation	Role
Christoph Huenseler, Dr med	Neonatology, Children's Hospital, University of Cologne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neonatology, Children's Hospital, University of Cologne	Recruiting	Cologne		50672	Germany

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia
D047928	Premature Birth

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided