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Breast milk vs 24% sucrose for procedural pain relief in preterm neonates: a non-inferiority randomized controlled trial

Abstract

Objectives

To compare the pain scores between the two groups, breast milk (BM) and 24% sucrose, in preterm neonates undergoing automated heel lance for the blood draw.

Methods

The study is designed as a randomized, single-blinded, non-inferiority trial. Infants born between 30 1/7weeks and 36 6/7 weeks of gestation were randomly assigned to receive either 24% sucrose or expressed BM. The Premature Infant Pain Profile—Revised (PIPP-R) was utilized to provide pain scores.

Results

No differences were noted in the baseline characteristics between the two groups. The quantile regression estimates for PIPP-R scores during the procedure were statistically non-significant at all percentile levels of distribution (50%ile coefficient 0, 95% CI −0.49 to 0.49).

Conclusion

We conclude that BM is not inferior to 24% sucrose in providing analgesia during heel lance in moderate and late preterm infants.

Trial registration

This trial was registered at www.clinicaltrials.gov (identifier NCT04898881)

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Funding

Funding

This work was supported by an institutional grant from Sarnaik Endowment Grant, Detroit Medical Center.

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Authors and Affiliations

Authors

Contributions

Concept and Design: PV, MB, CT, FE, MLB, GN, and SJ; Acquisition, analysis, and interpretation of data: PV, FE, CT, SJ, and MB Randomization and treatment allocation: MLB; Statistical analysis: MB, and AF; Drafting of manuscript: PV; Critical revision of manuscript for important intellectual content: FE, CT, SJ, GN, and MB; Obtaining funding: PV and MB; Supervision: MB. PV and MB had full access to all the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Corresponding author

Correspondence to Pradeep Kumar Velumula.

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Competing interests

The authors declare no competing interests.

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Velumula, P.K., Elbakoush, F., Tabb, C. et al. Breast milk vs 24% sucrose for procedural pain relief in preterm neonates: a non-inferiority randomized controlled trial. J Perinatol 42, 914–919 (2022). https://doi.org/10.1038/s41372-022-01352-2

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