Prevention of the Procedural Pain in the Newborn (ACTISUCROSE)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Prevention of the Procedural Pain in the Newborn

Treatments: Procedure: saccharose versus breast-feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT02109263

RB 12.143

Details and patient eligibility

About

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)

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 37 to 42 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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114 participants in 2 patient groups, including a placebo group

saccharose

Experimental group

Description:

20% saccharose

Treatment:

Procedure: saccharose versus breast-feeding

breast-feeding

Placebo Comparator group

Description:

breast-feeding

Treatment:

Procedure: saccharose versus breast-feeding