Effect of Site on Pain in Preterm Neonates

Not Applicable

Completed

• Conditions: Great Premature Newborn
• Interventions: Biological: Blood puncture site

• Registration Number: NCT02872415
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-08-16
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-19
• Study Start: 2017-05-10
• Primary Completion: 2018-04-06
• Status Verified: 2023-05
• Study Completion: 2023-05-25
• Last Update Submitted: 2023-05-25
• Last Update Posted: 2023-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fingers like blood puncture site	Blood puncture site	Premature receiving a puncture blood on the finger
The forearm as blood puncture site	Blood puncture site	The child receives a puncture blood on the forearm

Primary Outcome Measures

Name	Time	Method
The pain assessment	12 months	Painful response using Premature Infant Pain Profile (PIPP)

Trial Locations

Locations (1)

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France