NCT02374281

Brief Summary

The management of the pain is a constant care concern in neonatal and maternity units. Many studies show an interest in the use of sugar solutions to reduce nociception during painful events in infants. However, these studies are based mainly on behavioral observation of the newborn but intrinsic mechanisms of analgesic power are not clearly understood for sucrose solutions. Our hypothesis is that the analgesic mechanism of sucrose solutions in infants involves a subcortical reactivity notably by action via the brain stem. To explore the intensity of pain and evaluate the subcortical activity, we will use 1) the analysis of heart rate variability (frequency indices whose HFnu) as a peripheral witness of subcortical functioning of the autonomic nervous system 2) electroacoustic analysis of the intensity of crying baby, 3) a composite pain score (DAN score).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 10, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 27, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

March 30, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

February 10, 2015

Last Update Submit

March 29, 2016

Conditions

NewbornNeonatal Screening

Keywords

NewbornNeonatal ScreeningAutonomic Nervous SystemPainnon-nutritive suckingsucrose administrationnociceptive actionElectro acoustical characteristics of crying

Outcome Measures

Primary Outcomes (1)

  • High frequency normalized index (HFnu)

    It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor.

    From 15 min before the painful care to 15 min after.

Secondary Outcomes (8)

  • Low frequency (LF and LFnu),

    From 15 min before the painful care to 15 min after.

  • Scale of hetero-assessment of pain (DAN)

    15 minutes after the painful care

  • Electro acoustical characteristic of crying newborn : Duration

    From 15 min before the painful care to 15 min after.

  • Frequency domain

    From 15 min before the painful care to 15 min after.

  • The time domain (SDNN, SDANN, pNN50).

    From 15 min before the painful care to 15 min after.

  • +3 more secondary outcomes

Study Arms (3)

Glucose sucking

EXPERIMENTAL

The newborn will receive one minute before the painful care either a compress with sucrose. The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Glucose 30% by oral route (1 ml).

Drug: Glucose sucking

Water sucking

ACTIVE COMPARATOR

The newborn will receive one minute before the painful care either a compress with water. The puncture made in the veins of the back of the hand, will be performed only once per patient per test. Sterile water by oral route (1 ml).

Drug: Water sucking

No sucking

PLACEBO COMPARATOR

The puncture made in the veins of the back of the hand, will be performed only once per patient per test.

Other: No sucking

Interventions

Glucose suckingDRUG
Also known as: Glucose PROAMP 30%, Laboratoires AGUETTANT
Glucose sucking
Water suckingDRUG
Also known as: Eau ppi, BRAUN
Water sucking
No suckingOTHER
No sucking

Eligibility Criteria

AgeUp to 8 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy Newborn in maternity unit of the Saint-Etienne University Hospital (France), to receive venipuncture for blood tests or neonatal screening test
  • Establishing consent form signed by the holder of parental authority

You may not qualify if:

  • Children suffering from a disease affecting the central nervous system.
  • Children treated with paracetamol oral solution (if cephalohematoma for example) or other analgesics (nalbuphine) or sedative, at the time of registration.
  • Newborns impregnated with a prepartum maternal analgesia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hugues PATURAL, MD PhD

    CHU de Saint-Etienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2015

First Posted

February 27, 2015

Study Start

December 1, 2014

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

March 30, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)