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OpenTrials
Completed

NCT Number: NCT02872415

Effect of Site on Pain in Preterm Neonates

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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Key information

Age range

3 hour–72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assistance Publique Hôpitaux de Marseille

Marseille, 13354, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood puncture site

Biological

Blood puncture site

Primary outcomes

  1. The pain assessment

    Time frame: 12 months

    Painful response using Premature Infant Pain Profile (PIPP)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Official study title

Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.

Acronym: NOBOBO

Important dates

Study start
2017
Primary completion
2018
Study completion
2023
First posted
Aug 19, 2016
Registry last updated
May 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.