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Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02381691
Enrollment
60
Registered
2015-03-06
Start date
2013-01-31
Completion date
Unknown
Last updated
2015-10-01

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

Conditions

Neonates Analgesy

Brief summary

Objective : To assess the analgesic effect of maternal breast milk odor in preterm neonates Design : A prospective, randomised, controlled, double blinded, monocentric trial. 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.

Interventions

OTHERmaternal breast milk odor
OTHERno odor

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 10 Days
Healthy volunteers
No

Inclusion criteria

* neonates fed with their mother breast milk, * 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

* neonates for whom no video was recorded during the venipuncture

Design outcomes

Primary

MeasureTime frame
clinical score assessment PIPP (Premature Infant Pain Profile)20 minutes

Secondary

MeasureTime frame
DAN score (Acute Pain of Newborn)20 minutes
salivary cortisol level20 minutes

Countries

France

Outcome results

None listed

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