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Randomized trial with soaps: what happens to a newborn baby's skin?

Hygiene method in bath and hydratation of newborn skin: benefit from the use oh pH physiological children's soap

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-9ky84vd
Enrollment
Unknown
Registered
2021-02-23
Start date
2018-08-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin and connective tissue diseases, Infant, Newborn, Skin, Soaps, Skin Care

Interventions

The 204 recruited newborns were randomized into 2 groups, into 2 groups, each one with 102 participants: the group that used mildly acidic infant liquid soap and the liquid soap commonly used in the m
E02.547.800

Sponsors

Universidade Federal do Paraná
Lead Sponsor
Universidade Federal do Paraná
Collaborator

Eligibility

Age
No minimum to 24 Hours

Inclusion criteria

Inclusion criteria: Newborns over 34 weeks of gestational age were included; newborns rooming-in accommodation; newborns whose guardians signed the Informed Consent Form.

Exclusion criteria

Exclusion criteria: Newborns with skin solution of continuity or dermatosis diagnosed at the first assessment, such as ichthyosis vulgaris, lamellar ichthyosis or atopic dermatitis; newborns with genetic or chromosomal change; newborns in phototherapy.

Design outcomes

Primary

MeasureTime frame
Increase in pH, verified through pH-metry and measured with the skin pH measurement instrument HI 99181 Portable Waterproof Skin pH Meter®, in the abdomen and thigh after bathing in the Control Group (p = 0.02 and 0.03, respectively), while in the Experimental Group there was no significant variation (p = 0.49 and 0.84, respectively), it was considered the minimum level of significance of 5% and minimum test power of 90% in the pre measurements and post-intervention. ;Erythema was more frequent in the Control Group (CG) after bathing (p <0.001), which did not occur in the Experimental Group (EG) (p = 0.86). When comparing erythema before and after bathing, there was an increase in erythema intensity after bathing in the CG (p <0.001), and a decrease in the EG (p = 0.04), such variation was obtained through the clinical evaluation performed by the same researcher. ;Before the bath, there was a greater frequency of desquamation in the Experimental Group (EG) compared to the Control Group (CG) (p = 0.04). When the peeling before and after the bath was compared, it decreased in the SG (p <0.001) and remained the same in the CG (p = 0.56), such variation was obtained through the clinical evaluation carried out by the same researcher.

Secondary

MeasureTime frame
In the frontal region, there was an increase in pH in the control and experimental groups after bathing (p <0.001), but without a statistically significant difference between them, verified through pH-metry and measured with the cutaneous pH measurement instrument HI 99181 Portable Waterproof Skin pH Meter®, even without the use of soap in this location, the minimum significance level of 5% and minimum test power of 90% in the pre- and post-intervention measurements were considered.

Countries

Brazil

Contacts

Public ContactLarissa;Larissa Topan;Topan

;

larissa_habib@icloud.com;larissa_habib@icloud.com+55-041-996489694;+55-041-996489694

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 22, 2026