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Effect of Site on Pain in Preterm Neonates (NOBOBO)

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ClinicalTrials.gov Identifier: NCT02872415
Recruitment Status : Recruiting
First Posted : August 19, 2016
Last Update Posted : December 12, 2017
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Brief Summary:

Numerous experimental and clinical studies have shown that preterm neonates are particularly sensitive to stress. Preterm neonates routinely undergo painful invasive procedures. Each situation causing pain or discomfort can alter their development and cause short term cardiovascular consequences but also have long-term neurocognitive influences. Repetitive procedural pain can also lead to changes in the pain sensitivity threshold therefore. The most common painful procedures are lancing for blood glucose testing. In adults, infants and term newborns, forearm blood glucose testing has been demonstrated to be less painful than conventional sites (heel, fingers). But data is lacking in preterm neonates.

The primary purpose of this study is to demonstrate a significant reduction in pain response during forearm blood lancing vs conventional sites (fingers, heel) in preterm neonates born up to 32 weeks gestation.

This study is an interventional multicenter (3 centers), randomized, double bind trial with a cross over assignment. 60 premature neonates born between 23 to 32 weeks.

Gestation with a postnatal age less than 72 hours that will undergo at least 3 blood glucose pricks will be included. The different sites will be randomly successively tested.


Condition or disease Intervention/treatment Phase
Great Premature Newborn Biological: Blood puncture site Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.
Actual Study Start Date : March 18, 2017
Estimated Primary Completion Date : January 18, 2018
Estimated Study Completion Date : January 18, 2018

Arm Intervention/treatment
Experimental: The forearm as blood puncture site
The child receives a puncture blood on the forearm
Biological: Blood puncture site
Blood puncture site

Placebo Comparator: Fingers like blood puncture site
Premature receiving a puncture blood on the finger
Biological: Blood puncture site
Blood puncture site




Primary Outcome Measures :
  1. The pain assessment [ Time Frame: 12 months ]
    Painful response using Premature Infant Pain Profile (PIPP)



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Ages Eligible for Study:   up to 72 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Premature neonates 23 to 32 weeks gestation
  • Infant born with a postnatal age greater than or equal to 3 hours and less or equal to 72 hours
  • Infant born with at least 3 blood glucose testing in less than 72 hours

Exclusion Criteria:

  • Severe congenital anomalies that could alter pain perception or expression
  • Extremities congenital anomaly impeding blood glucose testing on different sites
  • Infants born to mothers known to be receiving opiates
  • Severe haemodynamic disturb
  • Severe neurologic injury
  • Neonate with opioids or sedatives medications
  • No parental consent

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): NCT02872415


Contacts
Contact: Aurelie SAILLE, Coordinator 0491384043 aurelie.saille@ap-hm.fr
Contact: Urielle DESALBRES, Director 0491382747 drci@ap-hm.fr

Locations
France
Assistance Publique Hôpitaux de Marseille Not yet recruiting
Marseille, France, 13354
Contact: Aurelie SAILLE, Coordinator    0491384043    aurelie.saille@ap-hm.fr   
Principal Investigator: Isabelle LIGI, PH         
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Isabelle LIGI, PH    491384043 ext +33    isabelle.ligi@ap-hm.fr   
Contact: Aurélie SAILLE, PH    491384043 ext +33    aurelie.saille@ap-hm.fr   
Principal Investigator: Isabelle LIGI, PH         
Principal Investigator: Gwenn- Marie VERZAT, PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02872415     History of Changes
Other Study ID Numbers: 2016-18
2016-A01349-42 ( Registry Identifier: IDRCB )
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications