Oral Glucose in Pain Alleviation Among Term Neonates

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03190980
• Date of registration: 13/06/2017
• Prospective Registration: No
• Primary sponsor: Makassed General Hospital
• Public title: Oral Glucose in Pain Alleviation Among Term Neonates
• Scientific title: Efficacy and Safety of Oral Glucose in Pain Alleviation Among Healthy Term Neonates
• Date of first enrolment: May 1, 2017
• Target sample size: 244
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03190980
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: N/A

Countries of recruitment

Lebanon

Key inclusion & exclusion criteria

Inclusion Criteria:

- Estimated gestational age: 37 weeks-42 weeks

- Birth weight: 2500 grams- 4000 grams

- Mode of delivery: normal vaginal delivery

- Age: birth to 72 hours of life

- Apgar scores of at least 7 at 1 and 5 minutes

- Heart rate between 100 and 160 per minutes

- Blood O2 saturation = 95%

- No known congenital anomalies

Exclusion Criteria:

- They have history of birth trauma

- They are admitted to neonatal intensive care unit (NICU)

- They need respiratory support

- Their mothers are receiving sedatives or opioids during vaginal delivery



Age minimum: N/A
Age maximum: 72 Hours
Gender: All

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Other: 5% glucose

Other: Placebo

Other: 30% glucose

Primary Outcome(s)

Pain score [Time Frame: 2 minutes during the procedure]

Secondary Outcome(s)

Occurance of adverse events [Time Frame: 5 minutes after the procedure]

Secondary ID(s)

1722017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors