An interventional study of saccharose versus breast-feeding in Prevention of the Procedural Pain in the Newborn, sponsored by University Hospital, Brest. Completed at 1 site in France. Open to participants aged 37 Weeks to 42 Weeks. Per ClinicalTrials.gov, last updated 2025-12-03.
Sponsored by University Hospital, Brest · Not applicable, Interventional, and Prevention
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)
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.
262 studies on the registry are indexed under Breast Feeding; 112 are open to participants now.
This study's enrollment of 114 is above the median of 95 across 210 interventional studies indexed under Breast Feeding.
Browse Breast Feeding studies →University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
20% saccharose
Procedure: saccharose versus breast-feeding
breast-feeding
Procedure: saccharose versus breast-feeding
saccharose versus breast-feeding
Increase of the total concentration of haemoglobin
Increase of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.
Time frame: 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
Dosage of rate salivary cortisol
Salivary cortisol sampling
Time frame: before and after painful gesture
This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.
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University Hospital, Brest