A Survey of Neonatal Surgery Practices in India

Neonatal Disorder Clinical Trial

Official title:

Neonatal Surgeries in India: A Nationwide Survey Among Neonatal and Pediatric Specialists

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04326361
• Other study ID #: MMDU/IEC/109P
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: March 20, 2023

Study information

• Verified date: March 2020
• Source: Maharishi Markendeswar University (Deemed to be University)
• Contact: Asir J Samuel, MPT, PhD
• Phone: 8059930222
• Email: asirjohnsamuel[@]mmumullana.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 930
• Est. completion date: March 20, 2023
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 26 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disorder

Intervention

Procedure:
• Neonatal surgeries
Current practices of neonatal surgeries in India

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Maharishi Markendeswar University (Deemed to be University)	Maharishi Markandeshwar Medical College and Hospital, Kumarhatti, Solan, Maharishi Markendeswar Institute of Medical Sciences and Research, Mullana

References & Publications (4)

Bhatnagar SN, Sarin YK. Current trends in neonatal surgery in India. J Neonatal Surg. 2012 Apr 1;1(2):18. eCollection 2012 Apr-Jun. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire	Validated structured survey questionnaire will be circulated through SurveyMonkey	1 day (Once through cross-sectional survey)

External Links

•   A Pilot Study on Neonatal Surgical Mortality: A Multivariable Analysis of Predictors of Mortality in a Resource-Limited Setting.
•   Current Trends in Neonatal Surgery in India
•   Minimally invasive surgery in neonates and infants
•   Outcome of Care Provided in Neonatal Surgery Intensive Care Unit of a Public Sector Tertiary Care Teaching Hospital of India.