Skip to content

Prevention of the Procedural Pain in the Newborn

Breastfeeding Versus Saccharose for Prevention of the Procedural Pain in the Newborn

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02109263
Acronym
ACTISUCROSE
Enrollment
114
Registered
2014-04-09
Start date
2013-06-30
Completion date
2013-12-31
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of the Procedural Pain in the Newborn

Keywords

Breast-feeding, Saccharose, Breast-feeding newborn, cortical pain responses, near infrared spectroscopy (NIRS), Salivary rate cortisol, heel lance

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.

Interventions

PROCEDUREsaccharose versus breast-feeding

saccharose versus breast-feeding

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
37 Weeks to 42 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Increase of the total concentration of haemoglobinMeasure 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 minutesIncrease of the total concentration of haemoglobin (delta HbT) measured by the spectrometer during the intravenous injection.

Secondary

MeasureTime frameDescription
Dosage of rate salivary cortisolbefore and after painful gestureSalivary cortisol sampling

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026