Effect of Site on Pain in Preterm Neonates

• Register: ClinicalTrials.gov
• Last refreshed on: 5 June 2023
• Main ID: NCT02872415
• Date of registration: 16/08/2016
• Prospective Registration: Yes
• Primary sponsor: Assistance Publique Hopitaux De Marseille
• Public title: Effect of Site on Pain in Preterm Neonates NOBOBO
• Scientific title: Impact of Alternative Blood Glucose Testing Site (Forearm) on Pain Reduction in Preterm Neonates.
• Date of first enrolment: May 10, 2017
• Target sample size: 81
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02872415
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: Double (Participant, Investigator).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion 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



Age minimum: 3 Hours
Age maximum: 72 Hours
Gender: All

Health Condition(s) or Problem(s) studied

Great Premature Newborn

Intervention(s)

Biological: Blood puncture site

Primary Outcome(s)

The pain assessment [Time Frame: 12 months]

Secondary ID(s)

2016-18

2016-A01349-42

Source(s) of Monetary Support

Please refer to primary and secondary sponsors