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Effect of Site on Pain in Preterm Neonates (NOBOBO)

Primary Purpose

Great Premature Newborn

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood puncture site
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Great Premature Newborn

Eligibility Criteria

3 Hours - 72 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

The forearm as blood puncture site

Fingers like blood puncture site

Arm Description

The child receives a puncture blood on the forearm

Premature receiving a puncture blood on the finger

Outcomes

Primary Outcome Measures

The pain assessment
Painful response using Premature Infant Pain Profile (PIPP)

Secondary Outcome Measures

Full Information

First Posted
August 16, 2016
Last Updated
May 25, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02872415
Brief Title
Effect of Site on Pain in Preterm Neonates
Acronym
NOBOBO
Official Title
Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2017 (Actual)
Primary Completion Date
April 6, 2018 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Great Premature Newborn

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The forearm as blood puncture site
Arm Type
Experimental
Arm Description
The child receives a puncture blood on the forearm
Arm Title
Fingers like blood puncture site
Arm Type
Placebo Comparator
Arm Description
Premature receiving a puncture blood on the finger
Intervention Type
Biological
Intervention Name(s)
Blood puncture site
Intervention Description
Blood puncture site
Primary Outcome Measure Information:
Title
The pain assessment
Description
Painful response using Premature Infant Pain Profile (PIPP)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Hours
Maximum Age & Unit of Time
72 Hours
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Site on Pain in Preterm Neonates

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