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Trial record 9 of 68 for:    Amenorrhea: Clinical Trials

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

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ClinicalTrials.gov Identifier: NCT02381691
Recruitment Status : Unknown
Verified September 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Active, not recruiting
First Posted : March 6, 2015
Last Update Posted : October 1, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Neonates Analgesy Other: maternal breast milk odor Other: no odor Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Analgesic Effect of Maternal Breast Milk Odor in Preterm Neonates: a Randomised Controlled Trial
Study Start Date : January 2013
Estimated Primary Completion Date : January 2016

Arm Intervention/treatment
Experimental: 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.
Other: maternal breast milk odor
Placebo Comparator: no odor
In a second control group, venipuncture was performed to the neonate with an odorless diffusor.
Other: no odor



Primary Outcome Measures :
  1. clinical score assessment PIPP (Premature Infant Pain Profile) [ Time Frame: 20 minutes ]

Secondary Outcome Measures :
  1. DAN score (Acute Pain of Newborn) [ Time Frame: 20 minutes ]
  2. salivary cortisol level [ Time Frame: 20 minutes ]


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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02381691


Locations
France
Assistance Publique des Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Desalbres Urielle APHM

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02381691     History of Changes
Other Study ID Numbers: 2012-11
RC12_3630 ( Registry Identifier: APHM )
2012-A00360-43 ( Other Identifier: IDRCB )
First Posted: March 6, 2015    Key Record Dates
Last Update Posted: October 1, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs