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Study Protocol

Effect of Pulmonary Complications on Neonates with Bronchopulmonary Dysplasia: A Systematic Review Protocol

[version 1; peer review: awaiting peer review]
PUBLISHED 06 Jun 2024
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REVIEWER STATUS AWAITING PEER REVIEW

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

Introduction

Bronchopulmonary dysplasia (BPD) is a common chronic lung disease that affects premature infants and is characterized by disrupted alveolar and vascular development. Pulmonary complications significantly affect morbidity and mortality rates in neonates with BPD.

Aim

This systematic review aimed to outline a protocol for investigating the effects of pulmonary complications in neonates diagnosed with BPD.

Methods

A comprehensive search strategy will be implemented across electronic databases, including PubMed, MEDLINE, Embase, and Cochrane Library. Eligible studies will include primary research articles reporting pulmonary complications, such as pulmonary hypertension, respiratory infections, ventilator-associated events, and airway abnormalities among neonates diagnosed with BPD. Two independent reviewers screened the titles, abstracts, and full text of the identified articles for eligibility. Data extraction will be conducted using a predefined form, including study characteristics, participant demographics, types of pulmonary complications, and relevant outcomes. The methodological quality of the included studies will be assessed using appropriate tools, such as the Cochrane Risk of Bias Tool for randomized controlled trials.

Outcome measures

The primary outcomes of interest will include the prevalence and incidence of pulmonary complications among neonates diagnosed with BPD. Secondary outcomes will encompass the impact of pulmonary complications on clinical outcomes, such as respiratory morbidity, mortality rates, length of hospital stay, and neurodevelopmental outcomes. Narrative synthesis will be employed to summarize the findings of the included studies, and where applicable, a meta-analysis will be conducted to quantify the effects of pulmonary complications on neonatal outcomes.

Discussion

This systematic review protocol outlines a rigorous methodology for investigating the effects of pulmonary complications in neonates with BPD. The findings of this review will provide valuable insights into the burden of pulmonary complications in this vulnerable population, and inform clinical practice and future research endeavors aimed at improving the care and management of neonates with BPD.

Systematic Review Registration no. CRD42024524133

Keywords

Bronchopulmonary Dysplasia, neonates, physiotherapy, physical therapy, sensory stimulations.

Introduction

Bronchopulmonary dysplasia is a most commonly seen chronic lung disease in premature infants. Mechanical ventilation and oxygen therapy are required in acute respiratory distress and are mainly seen in neonates with minimal severity in the respiratory course.1 Neonatal respiratory distress syndrome (NRDS) was introduced in 1967 by Northway et al. The new author categorized this under syndrome with features that described airway histopathology.2 Preterm birth occurs before 295 days or before the 37th week of gestation, which causes 75% perinatal mortality.3 The incidence of bronchopulmonary complications increases as gestational birth age decreases. Higher incidences of preterm infants suffering from respiratory, gastrointestinal, and cognitive issues are seen even after their survival. The global incidence of bronchopulmonary dysplasia is 1-75%. The incidence rate in Asia is 18-85%.4 Bronchopulmonary dysplasia is defined as a chronic lung disease that affects or injures the premature lung, which requires mechanical ventilation or oxygen support therapy. It is primarily observed in moderate or late preterm neonates after initial respiratory distress syndrome (ARDS). It is further classified as classic or old.5 According to diagnostic criteria, BPD syndrome is diagnosed based on gestational age, assessment point, and severity of the neonates who require oxygen support of more than 21% for more than 28days. It is mostly observed in preterm infants born before 30 weeks or weighing less than 1,500 g. The short-to long-term complications of bronchopulmonary dysplasia include increased susceptibility to pulmonary infections, impaired tolerance to exercise, pulmonary hypertension, increased risk of cerebral palsy and developmental delay, lower IQ, impaired executive function, asthma and COPD.6

What impact does pulmonary complications in neonates have on the incidence of primary complications, such as respiratory distress syndrome with bronchopulmonary dysplasia, when compared to standard care? A Systematic Review will be conducted to investigate the efficacy and safety of this intervention, with the aim of improving both short- and long-term outcomes in preterm infants at risk of bronchopulmonary dysplasia.

Review question

“What is the impact of neonatal rehabilitation interventions on the respiratory function, growth and development, and other relevant outcomes in infants diagnosed with Bronchopulmonary Dysplasia (BPD)?”

Inclusion criteria

This study involved premature neonates diagnosed with Bronchopulmonary Dysplasia. Participants were diagnosed with bronchopulmonary dysplasia based on clinical criteria such as respiratory symptoms (e.g., oxygen requirements at 36 weeks postmenstrual age, difficulty breathing) and radiographic evidence consistent with BPD and/or histopathological confirmation. The studies involved neonates who had experienced pulmonary complications, including respiratory distress syndrome (RDS), pulmonary hypertension, pulmonary edema, pneumonia, and respiratory infection.

Intervention

No specific intervention was defined for this review protocol, as the focus was on evaluating the effect of pulmonary complications in neonates diagnosed with bronchopulmonary dysplasia.

Comparator

No specific comparator was defined for this review protocol, as the focus was on evaluating the effectiveness of pediatric rehabilitation interventions in infants with pneumonia.

Outcomes

The pre-specified main outcomes were resolution of Bronchopulmonary Dysplasia symptoms (e.g., oxygen requirements at 36 weeks postmenstrual age, difficulty breathing), improvement in respiratory function (e.g., oxygen saturation levels, respiratory rate), reduction in hospital length of stay, parental satisfaction, effect measures for the secondary outcomes, including incidence of respiratory failure, need for supplemental oxygen therapy, And Developmental outcomes at follow-up assessments with 95% confidence intervals, to quantify respiratory rehabilitation in infants with Bronchopulmonary Dysplasia.

Type of studies

Randomized Controlled trials and systematic reviews will be included. Non-randomized, cross-sectional studies; observational, descriptive studies; observational analytical research designs, such as case-control and cohort studies; and qualitative study designs, such as qualitative case studies and narrative studies, will be excluded. As there are no resources available for translating research written in languages other than English, only published and unpublished English-language studies will be included. Targeted studies published between 2000-2024 will were included.

Methods

The methods of this systematic review were developed and reported in compliance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). In accordance with these guidelines, the study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) with ID CRD42024524133.

Search strategy

The search approach was intended to include both published and unpublished articles. A preliminary, inclusive search strategy tailored for PubMed, incorporating MeSH (Medical Subject Headings), will subsequently be adapted for various databases, focusing on titles and abstracts.

Information sources

The following databases will be searched from inception: PubMed (MEDLINE), CINHAL (EBSCOhost), Embase (Elsevier), and Web of Science (Clarivate). Ongoing studies will include Google Scholar (https://scholar.google.com/).

Study selection

All identified references were gathered and exported to the reference management software Rayyan, and the initial duplicates were removed. The studies will then be imported into the online systematic review tool Rayyan.[18] The second phase of duplicate removal occurred within Rayyan. Title and abstract screening will be conducted independently by two reviewers (SD and SH) based on the review’s inclusion criteria. The second phase involves retrieving the full texts of studies meeting the criteria, which will be uploaded to Rayyan. Two reviewers (NB and PW) will independently assess the full text of the selected studies. Articles failing to meet the eligibility criteria will be excluded, with reasons for exclusion provided in the appendix of the main systematic review. The search results and studies are depicted using a PRISMA flow diagram. Any disagreements among the reviewers will be resolved through discussion or by a third reviewer (RR or IQ) to reach a consensus.

Assessment of methodological quality and risk of bias

Studies will be selected based on predefined inclusion/exclusion criteria, and data extraction will involve relevant details such as study design, participant characteristics, interventions, outcomes, and follow-up periods, using a standardized form, with extraction and recording conducted independently by two reviewers. Discrepancies were resolved through consensus. In addition, a concurrent risk of bias assessment will be performed in publications using the Standards for Reporting Implementation Studies (StaRI)18 checklist and the PEDRO Scale.

Data extraction

Data extraction will involve collecting information on study characteristics, participant demographics, details of pediatric rehabilitation interventions, outcome measures, and results. Data extraction will be performed independently by two reviewers, and any discrepancies will be resolved through discussion or consultation with a third reviewer, if necessary.

Data synthesis

Data synthesis will involve a narrative synthesis of findings from the included studies, as well as meta-analysis, if feasible and appropriate, based on the homogeneity of study designs and outcome measures. Subgroup analyses may be conducted based on the type of pediatric rehabilitation intervention and severity of neonates with bronchopulmonary dysplasia.

Study status

Piloting of the study selection process is being undertaken.

Discussion

Multimodal stimulation interventions have the potential to positively influence respiratory outcomes in neonates by promoting relaxation, reducing stress responses, and enhancing the respiratory muscle tone. Auditory stimulation, particularly exposure to the mother’s voice, can positively influence respiratory patterns in neonates. Research suggests that soothing sounds such as maternal lullabies or gentle speech can promote relaxation, which may indirectly benefit respiratory function.7 Auditory stimulation may help regulate breathing patterns and improve oxygenation in neonates with respiratory issues by fostering a calm environment. Visual stimulation plays a crucial role in the promotion of respiratory stability and development in neonates. Studies have shown that visual interactions, such as making eye contact with caregivers or mothers, can stimulate neural pathways involved in respiratory control.8 Vestibular stimulation through rocking movements can have a calming effect on neonates, and may help improve respiratory function. Gentle rocking motion can promote relaxation and reduce respiratory effort, leading to improved oxygenation and ventilation.9 Tactile stimulation, such as gentle caressing or skin-to-skin contact, can have profound effects on the respiratory outcomes in neonates. Studies have demonstrated that tactile experience can stimulate the release of endorphins and oxytocin, leading to decreased stress responses and improved respiratory stability.10 While olfactory and gustatory stimulation may not directly impact respiratory function, they can contribute to a conducive caregiving environment that supports respiratory health.11 Exposure to familiar scents, such as the mother’s odor or breast milk, can promote relaxation and reduce stress levels, which may indirectly benefit respiratory stability.12

Ethics and consent

Ethical approval and consent were not required.

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Brahmane N, Hullumani S, Umale N et al. Effect of Pulmonary Complications on Neonates with Bronchopulmonary Dysplasia: A Systematic Review Protocol [version 1; peer review: awaiting peer review]. F1000Research 2024, 13:587 (https://doi.org/10.12688/f1000research.150889.1)
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Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions

Comments on this article Comments (0)

Version 1
VERSION 1 PUBLISHED 06 Jun 2024
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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