Effect of Site on Pain in Preterm Neonates

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-10

Study Completion Date

2023-05-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Great Premature Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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The forearm as blood puncture site

The child receives a puncture blood on the forearm

Group Type EXPERIMENTAL

Blood puncture site

Intervention Type BIOLOGICAL

Blood puncture site

Fingers like blood puncture site

Premature receiving a puncture blood on the finger

Group Type PLACEBO_COMPARATOR

Blood puncture site

Intervention Type BIOLOGICAL

Blood puncture site

Interventions

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Blood puncture site

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

3 Hours

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No