A Pilot Randomized, Assessor-Blinded Controlled Trial
I. Introduction
Importance of Skin Barrier Function in Newborns
Newborn babies have delicate skin that serves as a crucial barrier against infection, water loss, and the entry of irritants and allergens. Maintaining the integrity and pH balance of this barrier is essential for healthy skin development. However, compared to adults, babies have a less developed epidermal barrier, making their skin more susceptible to damage and various skin problems. This vulnerability highlights the importance of establishing appropriate skin cleansing routines for newborns.
Lack of Evidence-Based Guidelines for Newborn Skin Care
Despite the significance of proper skin care for newborns, there is a surprising lack of high-quality evidence to guide best practices. Current guidelines offer conflicting recommendations, with some advocating for water-only bathing while others suggest the use of mild cleansers. This absence of clear evidence-based guidelines has led to inconsistencies in the information provided to parents and variations in newborn bathing practices.
Need for a Well-Designed Study
To address this gap in knowledge, researchers conducted a pilot study as a preliminary step towards designing a larger, more definitive trial. The primary objective was to compare the effects of using a specifically formulated infant skin-cleansing product versus water alone on skin barrier function in newborns. This pilot study aimed to gather essential baseline data and assess the feasibility of conducting a larger trial, ultimately contributing to the development of evidence-based recommendations for newborn skin care.
II. Methods
Pilot Randomized Controlled Trial Design
The research team employed a pilot randomized controlled trial (RCT) design to investigate the effects of different bathing methods on newborn skin. This type of study is considered the gold standard for evaluating the effectiveness of interventions, as it allows for a fair comparison between groups and minimizes bias.
Study Site and Population
The study was conducted at a large teaching hospital in the North West of England, where a significant number of babies are born each year. The researchers focused on healthy, full-term newborns less than 24 hours old, ensuring that the study population was relatively homogenous and minimizing the potential influence of confounding factors. Babies with specific skin conditions or those admitted to the neonatal unit were excluded to maintain the focus on healthy newborns and prevent any potential harm.
Recruitment and Randomization Process
Expectant mothers were provided with information about the study during the antenatal period and given the opportunity to consider participation. Following childbirth, interested mothers were approached for consent and asked to complete a questionnaire to determine their family history of atopic eczema. This information was used to stratify the randomization process, ensuring a balanced distribution of babies with and without a family history of atopic eczema between the two intervention groups. The randomization itself was conducted using sequentially numbered, sealed envelopes containing the group allocation (water only or cleansing product), ensuring that neither the researchers nor the participants knew the assigned group beforehand.
III. Results
Recruitment and Follow-up Challenges
Initially, the study aimed to conduct all assessments within the hospital setting. However, researchers encountered a higher than anticipated loss to follow-up rate, with many mothers finding it difficult to return to the hospital for scheduled appointments. To address this challenge and improve participant retention, the research team decided to shift the follow-up assessments to the home environment. This change proved successful, as it reduced the burden on families and allowed for more accurate measurements due to calmer babies in their familiar surroundings.
Reliability of Measurements
The study employed several instruments to assess skin barrier function, including a TEWL meter, a pH meter, and a corneometer. To ensure the reliability of these measurements, the same trained midwife conducted all assessments for each participant, and repeated measurements were taken to check for consistency. The results demonstrated good intra-rater reliability, indicating that the measurements were accurate and consistent across different time points and body locations.
No Significant Differences Between Groups
Despite the initial hypothesis that the cleansing product would be superior to water, the study found no consistent evidence of significant differences between the two intervention groups in any of the measured outcomes. This was true for TEWL, hydration, skin surface pH, and clinical observations of skin condition. Furthermore, there were no apparent differences between babies with and without a family history of atopic eczema, suggesting that the cleansing product did not have a detrimental effect on babies predisposed to this skin condition.
No significant difference between cleansing product and water: The study found no consistent evidence that using a specifically formulated infant skin-cleansing product was superior to bathing with water and cotton wool in terms of skin barrier function. This was observed in various measurements, including transepidermal water loss (TEWL), skin hydration, skin surface pH, and clinical observations of skin condition.
No difference based on family history of atopic eczema: The study did not find any significant differences in outcomes between babies with a family history of atopic eczema and those without, suggesting that the cleansing product did not negatively impact babies predisposed to this skin condition.
Compliance challenges: The study encountered challenges with participant compliance, as many mothers introduced additional products into their babies’ bathing routines despite instructions to avoid doing so. This highlights the need for careful consideration of compliance in future studies and potential adjustments to the study design, such as earlier assessment of the primary outcome.
Home-based assessments are valuable: The shift to home-based assessments proved successful in improving participant retention and obtaining more accurate measurements due to calmer babies in their familiar environment. This suggests that home-based assessments are a valuable approach for future research in this area.
IV. Discussion
Importance of Pilot Studies
This pilot study exemplifies the crucial role of pilot studies in informing the design of larger, definitive trials, especially when there is limited prior research in a specific area. The findings from this study provided valuable insights into the feasibility of conducting a larger trial on newborn bathing practices and highlighted several key considerations for future research.
Shifting to a Non-Inferiority Trial Design
One of the most significant findings of the pilot study was the lack of evidence to support the initial hypothesis that the cleansing product would be superior to water alone. Based on this observation, the researchers recommend shifting the focus to a non-inferiority trial design for the main study. This type of design aims to demonstrate that the cleansing product is not inferior to water in terms of its effects on skin barrier function, rather than proving its superiority.
Addressing Compliance Challenges
The pilot study also revealed challenges with participant compliance, as many mothers introduced additional products into their babies’ bathing routines despite instructions to avoid doing so. This highlights the importance of carefully considering the timing of the primary endpoint in the main trial. To minimize the impact of non-compliance, it may be necessary to assess the primary outcome measure earlier in the study period, before mothers are likely to deviate from the assigned bathing method.
Comparison with Recent RCTs
Since the completion of this pilot study, several relevant randomized controlled trials have been published, investigating the effects of different bathing practices on newborn skin. While these studies provide valuable information, they also have limitations, such as the lack of a priori primary outcomes and sample size calculations, making it difficult to assess the strength of their findings. Additionally, none of these studies utilized home-based assessments, which may introduce selection bias by only including families who are particularly committed to the study and potentially have different skin care practices compared to the general population.
Importance of Home-Based Assessments
The experience from this pilot study underscores the value of conducting assessments in the home environment. Home-based assessments not only improve participant retention but also provide a more realistic representation of typical newborn care practices. This approach reduces the potential for selection bias and increases the generalizability of the study findings.
V. Conclusion
Valuable Data and Insights for Future Research
This pilot study has made significant contributions to the field of newborn skin care by providing valuable baseline data on skin barrier function in newborns and offering important insights into the challenges and considerations for designing a larger, more definitive trial. The findings suggest that a non-inferiority trial design is more appropriate for future research, aiming to demonstrate that the cleansing product is not inferior to water alone in terms of its effects on skin barrier function.
Need for Further Research
Despite the valuable insights gained from this pilot study, further research is still needed to establish clear evidence-based guidelines for newborn skin care practices. A well-designed, adequately powered non-inferiority trial with a focus on home-based assessments would provide more robust evidence to guide parents and healthcare professionals in making informed decisions about the best bathing methods for newborns. This research has the potential to improve newborn skin health and contribute to the overall well-being of infants. what is the result of this study
Lavender, T., Bedwell, C., O’Brien, E., Cork, M. J., Turner, M., & Hart, A. (2011). Infant skin-cleansing product versus water: A pilot randomized, assessor-blinded controlled trial. BMC Pediatrics, 11(35).
https://doi.org/10.1186/1471-2431-11-35
