NCT04898881

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

Completed Phase 4 Last updated 24 May 2021

What this trial tests

Phase 4 trial testing Breast Human Milk in Pain in 88 participants. Completed in 7 May 2021.

Timeline

1 January 2020

Primary endpoint
7 May 2021

7 May 2021

Quick facts

Lead sponsor	Wayne State University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	88
Start date	1 January 2020
Primary completion	7 May 2021
Estimated completion	7 May 2021
Sites	1 location across United States

Drugs / interventions tested

• Breast Human Milk
• 24 % Sucrose

Conditions studied

• Pain — all drugs for Pain →

Sponsor

Wayne State University

Who can join

Adults 1 Day to 30 Days, any sex, with Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sucrose analgesia for heel-lance procedures in neonates.
   Yamada J, Bueno M, Santos L, Haliburton S, et al · · 2023 · cited 20× · PMID 37655530 · DOI 10.1002/14651858.cd014806
2. Breast milk vs 24% sucrose for procedural pain relief in preterm neonates: a non-inferiority randomized controlled trial.
   Velumula PK, Elbakoush F, Tabb C, Farooqi A, et al · · 2022 · cited 9× · PMID 35197549 · DOI 10.1038/s41372-022-01352-2