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



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.


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.


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).


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 (identifier NCT04898881)

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

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Authors and Affiliations



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.

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Correspondence to Pradeep Kumar Velumula.

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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).

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