A Survey of Neonatal Surgery Practices in India

NCT ID: NCT04326361

Last Updated: 2020-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

930 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-03-20

Brief Summary

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The study will follow a cross-sectional survey design. The target population for the survey was neonatologists, paediatricians, paediatric surgeons and neonatal surgeons treating the newborn infants. The study will be nationwide survey of neonatal specialists regarding the common neonatal surgeries performed in the tertiary care teaching hospital in India. This cross-sectional survey study will commence once the project is approved by DST's Start-up Research Grant (SRG) approval committee and will continue for the period of two years. The protocol of this study was approved by the Institutional Ethics committee of the recognized tertiary care teaching university and will be conducted in accordance with the declaration of Helsinki guideline (Revised) 2013 and Indian Council of Medical Research guidelines 2017.

Detailed Description

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The survey instrument will be a validated structured survey questionnaire. The content validity of the structured questionnaire will be reported in terms of validity index (CVI), using ratings of item relevance by content experts.1 The content validation of identified items will be executed by the online Delphi method. Initially first round of Delphi survey of contentment validation will be carried out to achieve a consensus of 80% agreement among the identified panel of 10 experts in the field of neonatology will be consulted during the content validation in each round. If not achieved in first round, second round of Delphi survey of contentment validation will be carried out to achieve a consensus of 80% agreement among the identified panel of 10 experts. As more than 10 experts were deemed to be unnecessary, we will not include more than panel of 10 experts in each Delphi survey. The survey instrument will be created on an online survey platform (Survey Monkey). It was evaluated for both face and content validity by the investigators and approved by the experts. The survey will be pilot tested on a group of neonatologists and pediatricians before distribution. The survey will be administered electronically via email along with instructions and a hyperlink to the survey. The participants will be notified of the voluntary nature of participation, confidentiality and non-compensation for participation. Lists of email addresses of neonatologists and neonatal practitioners were assembled by liaising with the Neonatology Chapter of Indian Academy of Pediatrics (IAP Neochap). The invitation will be sent to the 800 neonatologists and pediatricians nationwide in India. To encourage response rates, an additional survey reminder will be emailed 1 week later.Each question will be validated and reported in term of I-CVI. The overall validation of proposed scale with item pool will be reported with S-CVI after the end of each Delphi method of scale validation. S-CVI will be computed by both approaches, universal agreement calculation method (S-CVI/UA) and averaging calculation method (S-CVI/Ave).Lynn recommended that minimum I-CVI of 0.78, in case of 6 to 10 experts and overall the scale should an SCVI/Ave of 0.90 or higher for considered to have excellent content validity.

Conditions

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Neonatal Disorder

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Neonatal surgeries

Current practices of neonatal surgeries in India

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Years of experience, level of neonatal care provided,
* type-severity-number of patients seen monthly (preterm infants, intubation with assisted ventilation, birth asphyxia/hypoxic ischemic encephalopathy), and availability of pediatric subspecialists including neonatal surgeon,
* students pursuing post-graduation in neonatal and Pediatric surgery.

Exclusion Criteria

* Undergraduate Bachelor of medicine and Bachelor of Surgery (MBBS) students,
* students who are not willing to participate in the study.
Minimum Eligible Age

26 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maharishi Markendeswar University (Deemed to be University)

OTHER

Sponsor Role lead

Responsible Party

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Asir John Samuel

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Neha Sharma, MPT

Role: PRINCIPAL_INVESTIGATOR

Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

Central Contacts

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Asir J Samuel, MPT, PhD

Role: CONTACT

8059930222

References

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Bhatnagar SN, Sarin YK. Current trends in neonatal surgery in India. J Neonatal Surg. 2012 Apr 1;1(2):18. eCollection 2012 Apr-Jun. No abstract available.

Reference Type BACKGROUND
PMID: 26023377 (View on PubMed)

Siddharth V, Gupta SK, Agarwala S, Satpathy S, Goel P. Outcome of Care Provided in Neonatal Surgery Intensive Care Unit of a Public Sector Tertiary Care Teaching Hospital of India. J Indian Assoc Pediatr Surg. 2019 Oct-Dec;24(4):257-263. doi: 10.4103/jiaps.JIAPS_177_18.

Reference Type BACKGROUND
PMID: 31571756 (View on PubMed)

Lin T, Pimpalwar A. Minimally invasive surgery in neonates and infants. J Indian Assoc Pediatr Surg. 2010 Jan;15(1):2-8. doi: 10.4103/0971-9261.69133.

Reference Type BACKGROUND
PMID: 21180496 (View on PubMed)

Puri A, Lal B, Nangia S. A Pilot Study on Neonatal Surgical Mortality: A Multivariable Analysis of Predictors of Mortality in a Resource-Limited Setting. J Indian Assoc Pediatr Surg. 2019 Jan-Mar;24(1):36-44. doi: 10.4103/jiaps.JIAPS_30_18.

Reference Type RESULT
PMID: 30686886 (View on PubMed)

Related Links

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https://www.ncbi.nlm.nih.gov/pubmed/30686886

A Pilot Study on Neonatal Surgical Mortality: A Multivariable Analysis of Predictors of Mortality in a Resource-Limited Setting.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4420385/

Current Trends in Neonatal Surgery in India

https://www.ncbi.nlm.nih.gov/pubmed/31571756

Outcome of Care Provided in Neonatal Surgery Intensive Care Unit of a Public Sector Tertiary Care Teaching Hospital of India.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2998663/

Minimally invasive surgery in neonates and infants

Other Identifiers

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MMDU/IEC/109P

Identifier Type: -

Identifier Source: org_study_id

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