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NCT04898881 · ClinicalTrials.gov registry record · Phase 4
Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance
A Phase 4 study, sponsored by Wayne State University.
- Completed
- Registry status
- Phase 4
- Development phase
- 88
- Enrollment target
NCT04898881: Completed Phase 4 study, sponsored by Wayne State University.
NCT04898881 is a Phase 4 study that has completed, run by Wayne State University. The registered enrollment target is 88 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04898881, a Phase 4 study, has completed, sponsored by Wayne State University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 88 participants
- Enrollment target
Study 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 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.
Primary Outcome
Premature Infant Pain Profile- Revised pain profile is used to give pain scores to the participants. Minimum score and maximum scores on the scale are zero and twenty one. The pain scores increases with increasing severity of pain.
Interventions
- OTHER Breast Human Milk
- OTHER 24 % Sucrose
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 88 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2021-05-07 |
| Phase | Phase 4 |
What the finished NCT04898881 record still lists
NCT04898881 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Breast Human Milk is the first listed.
NCT04898881 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04898881 about?
NCT04898881 is a clinical study titled "Breast Milk vs Sucrose in Relieving Procedural Pain in Preterm Neonates During Blood Draw by Automated Heel Lance". 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 g...
What is the current status of trial NCT04898881?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2020-01-01. Estimated completion is 2021-05-07.
What interventions are being tested in trial NCT04898881?
The interventions under investigation include: Breast Human Milk (OTHER), 24 % Sucrose (OTHER).
Who is sponsoring clinical trial NCT04898881?
This trial is sponsored by Wayne State University, which has 163 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04898881's enrollment target sits among peer trials
88 916th of 2000 higher than 1,078 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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