Skip to main content
OpenTrials
Completed

NCT Number: NCT02109263

Prevention of the Procedural Pain in the Newborn

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Prevention of the Procedural Pain in the Newborn Behavior Breast Feeding Feeding Behavior

Age range

37 week–42 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier universitaire

Brest, 29200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

saccharose versus breast-feeding

Procedure

saccharose versus breast-feeding

Primary outcomes

  1. Increase of the total concentration of haemoglobin

    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

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

Secondary outcomes

  1. Dosage of rate salivary cortisol

    Time frame: before and after painful gesture

    Salivary cortisol sampling

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study title

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

Acronym: ACTISUCROSE

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 9, 2014
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.