"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose... | NCT02803723

Studies
"Holding-cuddling" Plus Oral Sucrose Versus Oral Sucrose for Reducing Venipuncture Pain in Newborns and Infants

NCT02803723

Sponsor

Centre Hospitalier Universitaire de la Réunion

Status

Completed

Last Update Posted

Feb 11, 2020Actual

Enrollment

68Actual

Phase

Not Applicable

Conditions

Blood Sampling

Interventions

Holding-cuddling
Sucrose

Countries

Not provided

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

May 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016Actual

Primary Completion Date

Jun 2018Actual

Completion Date

Jun 2018Actual

First Submitted Date

May 30, 2016

First Submission Date that Met QC Criteria

Jun 16, 2016

First Posted Date

Jun 17, 2016Estimated

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 10, 2020

Last Update Posted Date

Feb 11, 2020Actual

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

"Holding-cuddling" plus oral sucrose versus oral sucrose for reducing venipuncture pain in newborns and infants.

Neonates and infants routinely undergo venipuncture in pediatric and neonatal intensive care units.

Such procedure is painful and several units administer 24% oral sucrose with pacifier during venipuncture, as this non-pharmacological intervention is considered safe and effective for procedural pain relief in infants from birth to 3 months of age. However, several studies point out that further research is needed to assess its efficacy in combination with other behavioral interventions for analgesia during painful procedures. Current knowledge suggests that multisensorial stimulation associated with oral sucrose could allow even more effective analgesia. To date, the studied stimulation strategies are based on massage, voice, eye contact and fragrance during heel prick. The "holding-cuddling" - that is the fact of holding the child in a safe, reassuring and warm position during the examination or medical intervention is promoted by various hospitals in order to favor the comfort of all the caregivers during such a procedures. This intervention should be primarily parents-driven but, in case of unavailability, it can be performed by the nursing staff. The hypothesis of this study is that the combination of "holding-cuddling" plus oral sucrose in more effective than oral sucrose in diminishing behavioral pain response during a venipuncture in newborns or infants less than three-month-old.

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

68Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Holding-cuddling + Sucrose	Experimental	The Holding-cuddling is started 5 minutes before and the sucrose administration is started 2 minutes before blood sampling.	Procedure: Holding-cuddling Procedure: Sucrose
Sucrose alone	Active Comparator	The sucrose administration is started 2 minutes before blood sampling.	Procedure: Sucrose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Holding-cuddling	Procedure	The "Holding-cuddling" is started 5 minutes before veinipuncture.	Holding-cuddling + Sucrose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of Pain	Measure of pain by DAN scale at the time of the veinopuncture	At 0 and 30 seconds after the veinopuncture

Secondary Outcomes

Measure	Description	Time Frame
Cardiac Frequency	Measure of the cardiac frequency at the time of the veinopuncture and 30 seconds after	At 0 and 30 seconds after veinopuncture
Oxygen saturation	Measure of the oxygen saturation at the time of the veinopuncture and 30 seconds after

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hospitalization at CHU de la Réunion - site sud in Neonatal Intensive Care Unit or Neonatology Unit. (Neonate reanimation, pediatric reanimation or Neonatology services)
Informed consent from holder(s) of the parental authority

Exclusion Criteria:

Intubated ou sedated patients
Treated with a combined analgesic during venipuncture
Having indications against sucrose
For which behavorial items from DAN scale are difficult to evaluate regarding their pathology (ex: severe neuromotor handicap)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Francesco BONSANTE, MD	CHU de La Réunion	Principal Investigator
Silvia IACOBELLI, MD	CHU de La Réunion	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013395	Sucrose

Ancestor Terms

ID	Term
D004187	Disaccharides
D009844	Oligosaccharides
D011134	Polysaccharides
D002241	Carbohydrates

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Browse Branches

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