Prevention of the Procedural Pain in the Newborn

Not Applicable

Completed

• Conditions: Prevention of the Procedural Pain in the Newborn
• Interventions: Procedure: saccharose versus breast-feeding

• Registration Number: NCT02109263
• Lead Sponsor: University Hospital, Brest

Brief Summary

The aim of this study is to compare the impact of two non-medicinal strategies: the breast-feeding and saccharose to measure effects in cerebral cortex during pain using near infrared spectroscopy (NIRS)

Detailed Description

Many studies of non-medicinal treatments(saccharose and breast-feeding)show a decrease of expression of pain in newborn. However Slater and al questioned these practices due to the absence of modification of the cerebral answer measured by evoked potential.

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted QC: 2014-04-04
• Study First Posted: 2014-04-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-21
• Last Update Posted: 2015-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Gestationnel age included between 37 and 42 weeks
• Born in the CHRU of Brest
• Breast-Fed
• Score of Apgar upper to 7
• No pathology malformative
• Absence of known chromosomal abnormality
• Consent of parents

Exclusion Criteria

• Maternal drug use
• Morphinic treatment
• Barbiturate treatment
• Benzodiazépine treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
breast-feeding	saccharose versus breast-feeding	breast-feeding
saccharose	saccharose versus breast-feeding	20% saccharose

Primary Outcome Measures

Name	Time	Method
Increase of the total concentration of haemoglobin	Measure two minutes before painful gesture, at the moment of painful gesture and 2 minutes after painful gesture. The newborn will be followed for the duration of hospital stay, an expected average of 30 to 60 minutes	Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.

Secondary Outcome Measures

Name	Time	Method
Dosage of rate salivary cortisol	before and after painful gesture	Salivary cortisol sampling

Trial Locations

Locations (1)

Centre hospitalier universitaire; 🇫🇷 Brest, France