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Infection in preterm infants receiving topical emollient oil massage: a systematic review and meta-analysis of randomised control trials
  1. Fekadeselassie Belege Getaneh1,
  2. Aden Asmare2,
  3. Bezabih Abayneh3,
  4. Endalk Birre1,
  5. Anissa Mohammed4,
  6. Amare Muche4,
  7. Alemu Gedefie5,
  8. Yibeltal Asmamaw1,
  9. Zemen Mengesha6,
  10. Natnael Moges7,
  11. Dires Mihretie Birhanu8,
  12. Zebenay Workneh Bitew9,
  13. Asressie Molla4
  1. 1Pediatrics and child health nursing, Wollo University, Dessie, Ethiopia
  2. 2NICU, Dessie Hospital, Desse, Ethiopia
  3. 3Debre Berhan University, Debre Berhan, Amhara, Ethiopia
  4. 4Public health, Wollo University, Dessie, Ethiopia
  5. 5Medical Laboratory, Wollo University, Dessie, Ethiopia
  6. 6Nursing, Wollo University, Dessie, Ethiopia
  7. 7Pediatrics and child health Nursing, Debre Tabor Univeristy, Debre Tabor, Ethiopia
  8. 8Pediatrics and child health nursing, Dilla University College of Health Sciences, Dilla, Ethiopia
  9. 9Pediatrics and child health nursing, St. Paul’s Hospital Millennium Medical College, Addis Ababa, Ethiopia
  1. Correspondence to Mr Fekadeselassie Belege Getaneh; fekadebelege{at}gmail.com

Abstract

Background Preterm infants are highly susceptible to infections, which significantly contribute to morbidity and mortality. This systematic review and meta-analysis investigated the effectiveness of topical emollient oil application in preventing infections among preterm infants.

Methods A comprehensive search was conducted across multiple electronic databases (PubMed, Cochrane, Scopus, Clinical trials, Epistemonikos, HINARI and Global Index Medicus) and other sources. A total of 2185 articles were identified and screened for eligibility. The quality of included studies was assessed using the Cochrane Risk of Bias Tool for randomised controlled trials. Data analysis was performed using StataCrop MP V.17 software. Heterogeneity among the studies was evaluated using the I2 and Cochrane Q test statistics. Sensitivity and subgroup analyses were conducted. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist guided the presentation of the results.

Results Of 2185 retrieved articles from initial searches, 11 met eligibility criteria and were included in the final analysis. A random effects meta-analysis revealed that infants who received massages with emollient oils had a 21% reduced risk of infection (risk ratio=0.79, 95% CI 0.64 to 0.97, I2=0.00%). Subgroup analyses indicated that preterm babies who received topical emollient oil massages with coconut oil, administered twice a day for more than 2 weeks, had a lower likelihood of acquiring an infection compared with their non-massaged counterparts.

Conclusion It is quite evident from this analysis that topical emollient oil application in preterm neonates is most likely effective in preventing infection. However, further studies, particularly from the African continent, are warranted to support universal recommendations.

  • Epidemiology
  • Neonatology
  • Nursing Care
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Introduction

Prematurity is indeed a significant health concern, with high mortality rates and potential long-term consequences for survivors. According to the Global Burden of Disease, prematurity is the most common illness worldwide.1 It is estimated that over a million newborns globally die each year due to infections and complications related to premature birth, out of a total of 15 million preterm births.2 Due to the lack of a naturally occurring protective cutaneous biofilm, preterm newborns are at heightened susceptibility to infections.3 4

In an effort to reduce preventable newborn deaths and stillbirths by 2035, the WHO and UNICEF introduced the Every Newborn Action Plan in 2014.5 Simple and cost-effective interventions have the potential to manage or prevent approximately 70%–80% of neonatal deaths.6 However, inadequate implementation of accessible, affordable and appropriate maternal and infant care disproportionately impacts low- and middle-income countries.7

The purpose of developing and implementing guidelines is to effectively organise and present the most up-to-date evidence to support clinical decision-making, with the goal of improving the quality of care, patient outcomes and cost-effectiveness.8 Unfortunately, in numerous countries, evidence-based, active implementation strategies are often disregarded or implemented incorrectly.9

The practice of massaging newborn babies with different types of oils is a traditional custom in many regions due to its perceived potential advantages.10 11 The WHO presently provides recommendations for skin care measures for preterm neonates based on evidence-based guidelines.12 However, there is conflicting research regarding the effectiveness of various emollient oils, such as sunflower, coconut, mustard and vegetable oils, when applied topically in skin care products, despite their widespread use and increasing popularity.

Emollient oils have been recognised for their potential benefits in maintaining the integrity of the skin, reducing water loss and providing moisturisation for premature babies.13–15 However, it is important to note that some studies13 16 17 have not found significant differences in infection rates, skin health or other outcomes when comparing the use of emollient oils to not using them. Additionally, there is evidence suggesting a potential association between oil massage and the risk of allergic reactions, necrosis and uraemia.18 19 These findings highlight the need for careful consideration and further research regarding the use of emollient oils and oil massage in the care of premature babies, taking into account potential risks and benefits. Therefore, the objective of this study was to gather and summarise existing information on the effects of topical emollient oil treatments on infections in preterm newborns.

Methods and materials

Protocol registration

The systematic review and meta-analysis described in this document were registered in the International Prospective Register of systematic reviews (PROSPERO) under the protocol ID CRD42023413770. However, it should be noted that the registered PROSPERO protocol pertains to a broader review, and adjustments are required to finalise the scope of this specific systematic review focusing on emollients. Moreover, the study results comply with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses reporting checklist for systematic reviews and meta-analyses (online supplemental table 1).

Supplemental material

Eligibility criteria or inclusion criteria

For the final analysis, each eligible article was independently evaluated by FSB and AG based on specific criteria. The inclusion criteria consisted of randomised controlled trials (RCTs) worldwide that examined the impact of emollient oil on infections in preterm neonates. Articles published or available as grey literature since 2000 and written in English or easily translatable to English were considered.

Search strategies and study selection process

To ensure a comprehensive literature search, three investigators (FBG AG and ZM) conducted independent searches on various databases and grey literature sources. The databases searched included PubMed, Cochrane, Scopus, Clinical trials, Epistemonikos, HINARI and Global Index Medicus. In addition, grey literature sources such as Google Scholar and ScienceDirect were also searched.

The search was conducted within a specific timeframe, from July 5 to July 13, 2023. To optimise the search strategy, the investigators used population, intervention, comparison and outcomes or sensitive searches. These searches involved combining text words using Boolean operators with indexing term guidance (online supplemental table 2). A cross-reference search was conducted to include any additional relevant research that may have been missed in the initial database search.

Supplemental material

After conducting the electronic database search, the research findings were uploaded to Endnote and Rayyan web applications to manage duplicate publications. Two investigators (FBG and AG) independently screened the articles based on their titles and abstracts. Following this initial screening, a thorough evaluation of the full-text publications was performed to assess their eligibility according to pre-established inclusion criteria. In cases of disagreement, discussions were held with other reviewers (ZM) to reach a consensus on which studies to include in the final selection for the systematic review and meta-analysis.

Quality assessment

The principal investigator, in collaboration with the coauthor (YA), independently assessed the quality of each publication using the Cochrane Risk of Bias Tool for RCTs. This tool consists of seven aspects and three possible bias levels: low risk, high risk and unclear risk20 After completing the quality assessment, the data were categorised as good, fair or poor quality based on the Agency for Healthcare Research and Quality guidelines. These categories were used to facilitate understanding (online supplemental table 3). Any discrepancies between the two reviewers who conducted the full-text screening were resolved through discussion with the third author (AA).

Supplemental material

Data extraction and management

The data extraction process used a pretested and structured data extraction checklist, which was adapted from the Cochrane Collaboration data extraction format for interventional reviews of RCTs. Two reviewers, FBG and AG, independently extracted relevant data from the included studies. The extracted data encompassed information such as the last name of the first author, publication year, study setting, frequency of application, dose and type of emollient oil, duration of intervention, sample size, comparison groups and the number of cases and non-cases in the intervention and control groups. Microsoft Word 2013 was employed to summarise this information.

During the inclusion process, there were no disagreements between the reviewers regarding the selection of papers. Studies that were incomplete or for which full texts could not be obtained despite attempts to contact the corresponding authors were excluded. Lastly, all investigators examined each included article to ensure the accuracy and comprehensiveness of the data.

Measurement of outcome variables

The primary objective of this systematic review and meta-analysis was to estimate the risk of infection among preterm neonates who received topically applied emollient oil compared with their counterparts. The effect of emollient oil on the incidence of infections was assessed by calculating the pooled risk ratio (RR) along with its corresponding 95% CIs. Additionally, the secondary goal was to identify any adverse events associated with the administration of topical emollient oil in this population.

Data synthesis and statistical analysis

To provide a comprehensive overview of the included papers, a summary table was created. This table included details such as the author, year of publication, region of study, primary outcome, sample size, adverse events, quality score and other important findings. This summary table helped to describe the characteristics of the included studies. To estimate the pooled effect of emollient oil application on infections in preterm neonates, STATA V.17 software was used.

Heterogeneity across the studies was assessed using both graphical tools such as the forest plot and the Galbraith plot, as well as statistical tests such as Cochran’s Q test and the I2 test. The I2 test values of 25%, 50% and 75% were considered representative of moderate, medium and high heterogeneity, respectively. A significance level of p<0.05 in Cochran’s Q test indicated the presence of statistical heterogeneity among the studies.21

To identify and manage sources of heterogeneity among studies, various methods were employed. Random effect models, sensitivity analysis and subgroup analysis were conducted, considering factors such as types of emollient oil, duration, dose, frequency of intervention and quality score. Objective methods like Egger’s and Begg’s tests, along with graphical tests such as funnel plots, were used to assess publication bias.22 Non-parametric trim and fill analyses were additionally employed to address the potential influence of small studies.23 Finally, the results of this meta-analysis are presented through Forest plots, summary tables and textual descriptions.

Results

Study selection

Among the 2185 articles initially retrieved, 1563 were excluded due to duplication, and an additional 586 were deemed unrelated to the study’s objective based on title and abstract screening. From the remaining 36 articles that underwent full-text screening, 11 met the eligibility criteria and were included in the final analysis (figure 1 and online supplemental table 4).

Supplemental material

Figure 1

Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram pooled effect of topical emollient oil application on infection of preterm neonate, 2023.

Characteristics of the included studies

The studies that were taken into consideration for this review were all carried out between 2000 and 2023 in 10 different countries extended across four continents (Asia,4 14 18 24–29 Australia,30 and Europe31 and Africa13), and they examined the effects of emollient oil therapy on preterm baby infection prevention. 11 RCT studies4 14 18 24–31 that included 3965 preterm neonates (1954 in the intervention group and 2011 in the control group) were included in this study. Of the 11 studies, two were carried out in a rural setting,14 18 while the other nine were centred in institutions. The included study’s sample size varied from 3631 to 229414 preterm newborns. Topical emollient oils such as coconut14 18 26 29 30 sunflower oil,4 27 28 olive oil,25 iSio431 and aquaporin24 were applied to the preterm newborns in the intervention group. Out of the 11 studies, five have been published within the last 5 years (2018–2022).4 14 18 30 31 Based on the quality scores, the majority of the studies had good4 18 27–29 and fair quality14 24–26 30 31 scores, while one has been rated as poor quality.13 Lastly, only two study14 18 of the nine that examined the adverse events following topical emollient oil administration documented accidental slippage among the intervention groups and a considerably higher percentage of mothers expressed dissatisfaction or cumbersomeness with the application process of coconut oil (table 1).

Table 1

Characteristics of Included studies showed pooled effect of topical emollient oil application on infection of preterm neonate, 2023.

Effect of emollient oil on infection among preterm babies

In the current study, preterm newborns who received topical emollient oil massage had a 21% lower likelihood of infection compared with preterm babies who did not receive the massage (RR=0.79, 95% CI 0.64 to 0.97). The I2 test indicated low heterogeneity (I2=26.5%, p=0.19) (figure 2). To further investigate potential variations in RRs and provide specific recommendations, a subgroup analysis was conducted based on factors such as emollient oil type, duration of therapy, dose of therapy, frequency of therapy and study quality. Despite the lack of significant statistical heterogeneity between studies (I2=26.5%, p=0.19), the subgroup analysis aimed to explore potential differences in the risk ratios across these factors.

Figure 2

Forest plot showed the effect of emollient oil on preterm baby infection in a preterm neonate in 2023.

The subgroup analysis revealed several significant findings. Preterm infants who received topical emollient oil massages with coconut oil demonstrated a 39% reduced risk of infection compared with the control group (RR=0.61, 95% CI 0.43 to 0.88). Similarly, preterm infants who received massages two times a day and for more than 2 weeks showed a 40% (RR=0.60, 95% CI 0.38 to 0.94) and 31% (RR=0.69, 95% CI 0.51 to 0.95) lower risk of infection, respectively, compared with their non-massaged counterparts. Furthermore, studies with high-quality scores indicated a 35% reduced risk of infection in the intervention groups (RR=0.65, 95% CI 0.48 to 0.88) (table 2 and online supplemental figure 1).

Supplemental material

Table 2

Subgroup analysis showed pooled risk ratio effect of topical emollient oil application on infection prevention of preterm neonate, 2023.

A sensitivity analysis was conducted to assess the impact of excluding individual studies on the overall findings. The results indicated that none of the studies had a significant influence on the pooled estimates. The point estimates obtained by excluding each study fell within the CI of the combined analysis, which was reported as 0.64 to 0.97 with a 95% CI. This suggests that the overall results and conclusions of the study are robust and not heavily influenced by any single study.

The funnel plot was primarily used to assess publication bias. The asymmetrical distribution of studies in the funnel plot indicated a lack of small studies with negative outcomes. However, the results of Egger’s test (p=0.458) indicated that there was no significant publication bias present (figure 3).

Figure 3

Funnel plot showed the effect of emollient oil on preterm baby infection in a preterm neonate in 2023.

Discussion

The implementation of preventive measures to reduce the risk of infection is crucial for improving the health and survival of preterm infants, as neonatal infections are significant contributors to morbidity and mortality in this population. This systematic review and meta-analysis contribute evidence regarding the impact of emollient oil application on infection prevention in premature babies.

The findings of this review support the hypothesis that topical oil application can provide benefits for preventing infections beyond basic skin care. These results align with previous Cochrane reviews that have also suggested the potential advantages of emollient oil application for infection prevention in preterm infants.32 There are several potential reasons for the observed decrease in infection risk among the intervention group (those receiving topical emollient oil) in the study. One possible explanation is that the application of emollient oils enhances the function of the skin barrier. By creating a protective barrier on the skin, emollient oils can prevent the entry of microorganisms and reduce the risk of infection.11 33 Additionally, these oils have moisturising properties that can support the skin’s natural defenses and help maintain skin integrity, further reducing the risk of infection.34

Another notable finding of this study was that preterm neonates who received massages with coconut oil had a higher likelihood of preventing infection compared with the control groups. One possible explanation for this observation is that the fatty acid, linoleic acid and vitamin D content present in coconut oil may enhance its binding to peroxisome proliferator-activated α receptors on keratinocytes. This, in turn, can accelerate skin development and maturation, thereby preventing conditions like hypothermia and apnoea.31 35 Furthermore, coconut oil has demonstrated efficacy in preventing hypothermia and apnoea in preterm infants by reducing insensible water loss and minimising tactile stimulation during massage.14

Additionally, the findings of the study suggested that preterm newborns who received massages two times a day and for a duration longer than 2 weeks had a lower likelihood of developing infections compared with those who did not receive massages. This observation may be attributed to the indirect effects of frequent and prolonged massage on the immune systems of preterm newborns. Mechanical stimulation provided by oil massage can have a positive impact on the immune system. Previous research has indicated that receiving a massage can activate the parasympathetic nervous system, leading to relaxation and reduced stress levels.33 36 Oil massage, in particular, may contribute to strengthening the immune system of preterm newborns by lowering stress and promoting relaxation, which in turn could help reduce the risk of infection.37

The findings of this systematic review and meta-analysis hold significant importance for programme planners, policymakers and clinicians, particularly in regions with a high burden of prematurity. However, it is important to acknowledge certain limitations of the study. The analysis was unable to estimate the risk difference across different continents and ethnicities due to the scarcity of primary studies, particularly from Africa. Additionally, studies published in languages other than English, those with only abstracts available and those lacking sufficient details after communication attempts were excluded, potentially reducing the generalisability of the findings.

In conclusion, the analysis demonstrated that preterm neonates who received massages two times a day with coconut oil for an extended duration had a reduced risk of infection compared with those who did not receive such massages. These findings highlight the potential of topical emollient oil application to significantly improve the survival rate of preterm infants. Addressing the issue of preterm birth and reducing neonatal mortality requires the widespread adoption of low-cost, accessible interventions such as topical emollient oil application. Given the global public health impact of premature birth and associated mortality, further research and implementation efforts are warranted.

Ethics statements

Patient consent for publication

Ethics approval

Not applicable.

Acknowledgments

We are thankful to the authors of the original studies included in this systematic review and meta-analysis, and to those who contributed a lot in this work.

References

Footnotes

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  • Contributors All authors made a substantial contribution to this study. FBG, YA and AG conducted the systematic review (quality evaluation, study selection and data extraction). FBG designed the study and conducted the meta-analysis. NMM, DBM, AG and AA drafted the manuscript. AMo, AM, BA and ZM critically reviewed the manuscript, interpreted the findings and approved the final version. All authors had full access to all of the data in the study and can take responsibility for the integrity of the data and the accuracy of the data analysis. As the senior authors, AsM and ZWB affirm that the manuscript is an honest, accurate and transparent account of the study being reported.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests No, there are no competing interests.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.