New Study Finds Antiseptic Skin Wipes Don't Prevent Serious Infections in NICU Newborns

What a Large Trial from Pune, India, Tells Parents About Octenidine Skin Cleansing and Late-Onset Sepsis

A large clinical trial in a neonatal intensive care unit found that washing newborns once a day with an antiseptic skin wipe did not lower rates of serious bloodstream infection compared with washing with plain sterile water. Both approaches were equally safe, with mild, uncommon, and quickly resolving skin irritation in either group. The findings suggest that skin cleansing with this product alone is not enough, by itself, to prevent these infections in the NICU.

Background: Why Preventing Infections in the NICU Has Long Been a Challenge

Babies who are born very early, very small, or very sick often need weeks or even months of care in a neonatal intensive care unit (NICU) — the specialized hospital ward for newborns who need extra support. One of the things NICU teams worry about most is a baby developing a serious bloodstream infection sometime after the first few days of life; doctors call this "late-onset sepsis" because it shows up later than an infection a baby might already have had at birth. These infections can make an already fragile baby much sicker, and they often mean more tests, more medicines, and a longer hospital stay. Because the germs that cause these infections can live on a baby's skin before finding a way into the bloodstream — often through a small tube called an intravenous (IV) line or catheter — washing a baby's skin with something that kills germs has always seemed like a promising way to help prevent infection before it starts.

A newly published study set out to test one specific antiseptic product for exactly this purpose. Researchers at a single neonatal intensive care unit — Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital in Pune, India — enrolled 530 newborns of every gestational age, including babies born very early and babies born close to full term, within their first two days of life [1]. Half of the babies were washed once a day with wipes containing an antiseptic called octenidine, and half were washed once a day with plain sterile water and gauze, and the research team then tracked how many babies in each group went on to develop a serious late-onset infection.

This kind of study builds on years of related research. Scientists have long tried a similar antiseptic called chlorhexidine, washing premature and hospitalized newborns with it to see whether it changes the germs living on their skin and whether it lowers infection rates; several studies in India found that chlorhexidine washing changed skin germs and, in some analyses, appeared linked to fewer infections [2],[3],[4]. Outside of newborn care, large studies in adult and children's intensive care units found that daily bathing with chlorhexidine could reduce serious bloodstream infections in those older patients [5],[6]. But a major review of the evidence published in 2023 concluded that, for newborns specifically, there still was not strong proof about which skin antiseptic actually works best, or whether cleaning the skin prevents real infections rather than just temporarily reducing surface germs [7]. That uncertainty matters because late-onset sepsis is common enough to be a real concern: among the smallest and most fragile babies who survive their first days in a NICU, a meaningful share go on to develop it [8], and it has been linked to longer-term developmental struggles for some survivors [9] — which is exactly why researchers keep searching for reliable ways to prevent it before it starts.

What the Researchers Did

The study [1] randomly assigned each baby to one of the two cleansing routines, the way a coin flip decides an outcome, using sealed, numbered envelopes so that no one could predict or influence which group a baby would join. Any newborn admitted to the NICU within two days of birth, at any gestational age, could take part; babies were not included if their parents preferred not to participate, if they already had skin problems, if they had an infection detected within their first three days of life, or if they left the NICU before they were 3 days old. Families and bedside nurses could see which product was being used, since a wipe looks and feels different from water and gauze, but the two doctors who decided whether a baby actually had a late-onset infection did not know which group that baby was in, and neither did the laboratory staff or the statistician who analyzed the results — a safeguard designed to keep the judgment calls fair. In the wipe group, three premoistened cloths containing a 0.1% octenidine solution were used once a day during morning care: one for the upper body, one for the lower body, and one for the genital area, applied in that order and left to air-dry rather than rinsed off. The comparison group followed the exact same daily routine and schedule, using sterile water and gauze pads instead. Everything else about each baby's care, including cleaning the diaper area after every change, stayed the same in both groups. In total, 530 babies were randomized — 266 to the antiseptic wipes and 264 to sterile water — and the two groups were very similar at the start in terms of how early they were born, their birth weight, and other health factors, so any difference seen later would be more likely to reflect the cleansing routine itself rather than one group simply starting out sicker or healthier than the other.

What the Study Found

The study [1] found that, overall, 73 of the 530 babies (about 14%) developed a late-onset infection during the study, and the rate was nearly identical in both groups: 39 of 266 babies (about 15%) in the antiseptic-wipe group compared with 34 of 264 babies (about 13%) in the sterile-water group. Statistically, that small difference could easily have happened by chance alone — much like flipping two coins a few hundred times each and getting a slightly different number of heads, without either coin actually being different — and researchers confirmed this using a formal calculation (a "P value" of .60, where anything much above .05 generally means the difference is not considered statistically meaningful). Looking at infections in the first week of life, the two groups were almost exactly the same; in the second week, infections were numerically a little more common with sterile water than with the antiseptic wipes, and the typical time before an infection appeared was similar either way (about 6 days versus about 5 days). Babies in both groups spent a similar amount of time in the NICU (about 11 days versus about 10 days, typically) and in the hospital overall (about 14 days in both groups), and needed antibiotics for a similar length of time. A germ called Klebsiella was the most frequent cause of infection when one did occur, followed by another bacterium called Acinetobacter baumannii. One number needs careful handling: more babies in the antiseptic-wipe group died during the study than in the sterile-water group (12 out of 266 compared with 5 out of 264), but this difference was not statistically significant (P = .14), meaning it is very plausibly due to chance in a study of this size that was never designed to specifically measure differences in deaths; it should be read as raw counts worth knowing about, not as proof that the wipes caused harm. Reassuringly, skin reactions were mild, uncommon, and about equally likely with either product (roughly 6% of babies in each group), and every reaction healed within two days with no serious skin injury, burns, or blistering in either group.

What This Means for Families and What Researchers Are Working On Next

For parents whose baby is in a NICU, the most important message from this study is reassurance rather than alarm: neither cleansing routine caused harm, and this trial simply did not find that one particular antiseptic wipe protects a baby from serious late-onset infection any better than washing with plain sterile water does. If your baby's unit uses one approach or the other, or even both at different times, this study gives no reason for concern about either choice on its own. What the researchers themselves concluded is that a single skin-cleansing product, used by itself, is probably not enough to meaningfully lower a baby's infection risk — and that the more promising path forward is likely a combination of several prevention steps working together, such as careful hand hygiene, close attention to how IV lines and catheters are placed and cared for, and thoughtful use of antibiotics, all bundled into one coordinated approach that pediatric infection-prevention guidelines have long recommended rather than relying on any single tool [10]. Looking ahead, the researchers and others in the field are now focused on designing larger studies across multiple hospitals, directly measuring the germs living on a baby's skin before and after cleansing (something this study did not do), and specifically including enough of the very smallest and earliest-born babies, who face the highest risk of these infections and were somewhat underrepresented in this particular trial. None of that changes what this study actually showed: for the specific antiseptic and the specific comparison tested here, the wipes and the water performed the same, and both were safe.

References

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  2. Sankar MJ, Paul VK, Kapil A, Kalaivani M, Agarwal R, Darmstadt GL, Deorari AK. Does skin cleansing with chlorhexidine affect skin condition, temperature and colonization in hospitalized preterm low birth weight infants? A randomized clinical trial. J Perinatol. 2009;29(12):795-801. doi:10.1038/jp.2009.110 ↩
  3. Gupta B, Vaswani ND, Sharma D, Chaudhary U, Lekhwani S. Evaluation of efficacy of skin cleansing with chlorhexidine in prevention of neonatal nosocomial sepsis - a randomized controlled trial. J Matern Fetal Neonatal Med. 2016;29(2):242-247. doi:10.3109/14767058.2014.996126 ↩
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  5. Climo MW, Yokoe DS, Warren DK, et al. Effect of daily chlorhexidine bathing on hospital-acquired infection. N Engl J Med. 2013;368(6):533-542. doi:10.1056/NEJMoa1113849 ↩
  6. Milstone AM, Elward A, Song X, et al; Pediatric SCRUB Trial Study Group. Daily chlorhexidine bathing to reduce bacteraemia in critically ill children: a multicentre, cluster-randomised, crossover trial. Lancet. 2013;381(9872):1099-1106. doi:10.1016/S0140-6736(12)61687-061687-0) ↩
  7. Muhd Helmi MA, Lai NM, Van Rostenberghe H, Ayub I, Mading E. Antiseptic solutions for skin preparation during central catheter insertion in neonates. Cochrane Database Syst Rev. 2023;5(5):CD013841. doi:10.1002/14651858.CD013841.pub2 ↩
  8. Stoll BJ, Hansen N, Fanaroff AA, et al. Late-Onset Sepsis in Very Low Birth Weight Neonates: The Experience of the NICHD Neonatal Research Network. Pediatrics. 2002;110(2):285-291. doi:10.1542/peds.110.2.285 ↩
  9. Alshaikh B, Yusuf K, Sauve R. Neurodevelopmental outcomes of very low birth weight infants with neonatal sepsis: systematic review and meta-analysis. J Perinatol. 2013;33(7):558-564. doi:10.1038/jp.2012.167 ↩
  10. Polin RA, Denson S, Brady MT; Committee on Fetus and Newborn; Committee on Infectious Diseases. Strategies for prevention of health care-associated infections in the NICU. Pediatrics. 2012;129(4):e1085-e1093. doi:10.1542/peds.2012-0145 ↩