NCT02803723

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Typical duration for not_applicable

Status
completed

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

May 30, 2016

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

February 11, 2020

Status Verified

May 1, 2016

Enrollment Period

2 years

First QC Date

May 30, 2016

Last Update Submit

February 10, 2020

Conditions

Blood Sampling

Outcome Measures

Primary Outcomes (1)

  • 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 (3)

  • Cardiac Frequency

    At 0 and 30 seconds after veinopuncture

  • Oxygen saturation

    At 0 and 30 seconds after veinopuncture

  • Pain at 1 min

    1 min after veinopincture

Study Arms (2)

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-cuddlingProcedure: Sucrose

Sucrose alone

ACTIVE COMPARATOR

The sucrose administration is started 2 minutes before blood sampling.

Procedure: Sucrose

Interventions

Holding-cuddlingPROCEDURE

The "Holding-cuddling" is started 5 minutes before veinipuncture.

Holding-cuddling + Sucrose
SucrosePROCEDURE

The sucrose adminstration is started 2 minutes before veinipuncture.

Holding-cuddling + SucroseSucrose alone

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sucrose

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Francesco BONSANTE, MD

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

  • Silvia IACOBELLI, MD

    CHU de La Réunion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2016

First Posted

June 17, 2016

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

February 11, 2020

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will not share