Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
NCT ID: NCT02381691
Last Updated: 2015-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2013-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Méthods : The neonates were included from 01/01/2012 to 31/12/2014. Inclusion criteria were: neonates fed with their mother breast milk, gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days, a postnatal age ≤ 10 days and a birth weight greater than the 5th percentile according to Olsen curves et al. They also had to be: clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease. The two legal representatives must have signed an informed consent. The study excluded the neonates for whom no video was recorded during the venipuncture.
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused. In a second control group, the same gesture was made with an odorless diffusor. The primary outcome was the clinical score assessment PIPP (Premature Infant Pain Profile). The secondary outcomes were the DAN score (Acute Pain of Newborn) and the salivary cortisol level.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Breast Milk Odor on Pain Response and Salivary Cortisol Level in Preterm Infants
NCT05557435
The Effect of Breast Milk Odor on Feeeding in Preterm Infants
NCT06563973
The Effect of Exposure to Maternal Human Milk Odor on Physiological State of Preterms.
NCT01012505
Early Use of Raw Milk and Breastfeeding Continuation
NCT03938675
The Effect of Breast Milk Smell on Nutrition in Preterms
NCT04843293
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
maternal breast milk odor
In the first group "breast milk", venipuncture was performed to the neonate while his mother's milk odor was being diffused.
maternal breast milk odor
no odor
In a second control group, venipuncture was performed to the neonate with an odorless diffusor.
no odor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
maternal breast milk odor
no odor
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* gestational age between 30 weeks of amenorrhea and 36 weeks + 6 days,
* postnatal age ≤ 10 days
* birth weight greater than the 5th percentile according to Olsen curves et al.
* clinically stable, with 48 hours withdrawal of nasal CPAP, without administration of any analgesic or sedative drug in the last 48 hours and without any underlying disease
* the two legal representatives must have signed an informed consent.
Exclusion Criteria
10 Days
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Desalbres Urielle
Role: STUDY_DIRECTOR
APHM
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assistance Publique des Hopitaux de Marseille
Marseille, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RC12_3630
Identifier Type: REGISTRY
Identifier Source: secondary_id
2012-A00360-43
Identifier Type: OTHER
Identifier Source: secondary_id
2012-11
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.