Status:

COMPLETED

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

Lead Sponsor:

Wayne State University

Conditions:

Pain

Eligibility:

All Genders

1-30 years

Phase:

PHASE4

Brief Summary

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...

Detailed Description

Blood draw by automated heel lancet is a common painful procedure in the Neonatal Intensive care units (NICU). The cutaneous sensory receptors on all mucosal and cutaneous surfaces are developed by 20...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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

Key Trial Info

Start Date :

January 1 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 7 2021

Estimated Enrollment :

88 Patients enrolled

Trial Details

Trial ID

NCT04898881

Start Date

January 1 2020

End Date

May 7 2021

Last Update

May 24 2021

Active Locations (1)

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Detroit Medical center

Detroit, Michigan, United States, 48201