Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance

Completed · Phase 4

Conditions studied: Pain

In brief

Skin breaking procedure through an automated heel lancet for blood draws is a common painful procedure in the Neonatal Intensive care unit (NICU). Recurrent pain in preterm neonates is associated with long-term complications. The primary objective of the study is to compare pain scores between two groups (24% sucrose and breast milk) during blood draw using an automated heel lancet in preterm neonates. The investigator conducted a prospective randomized controlled trial in preterm neonates, to compare the pain scores in infants receiving either breast milk or sucrose. Premature Infant pain profile- Revised pain profile is used to assign pain scores. The primary outcome measure is the comparison of pain scores between the two groups.

Key facts

Study ID

NCT04898881

Run by

Wayne State University

People needed

88

Starts

2020-01-01

Expected to finish

2021-05-07

Last updated by the study team

2021-05-24

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• All Infants with gestational age between 30 1/7 and 36 6/7 weeks
• Within 30 days of post-natal life
• Breast milk is available for the neonate
• Scheduled for a blood draw

You may not qualify if…

• Neonates on intravenous or peroral medications for sedation/analgesia or anti-epileptics
• Infants diagnosed with neonatal abstinence syndrome and neonatal encephalopathy
• Infants who are critically ill, on assisted ventilation > 2L HFNC and on ionotropic support
• Infants with major congenital abnormalities/dysmorphism

Where it is running

• Detroit Medical center — Detroit, Michigan, United States

Full record on ClinicalTrials.gov

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