Prevention of the Procedural Pain in the Newborn

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2013-12-31

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Prevention of the Procedural Pain in the Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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saccharose

20% saccharose

Group Type EXPERIMENTAL

saccharose versus breast-feeding

Intervention Type PROCEDURE

saccharose versus breast-feeding

breast-feeding

Group Type PLACEBO_COMPARATOR

saccharose versus breast-feeding

Intervention Type PROCEDURE

saccharose versus breast-feeding

Interventions

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saccharose versus breast-feeding

Intervention Type PROCEDURE

Eligibility Criteria

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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