NCT04326361

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
930

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
1.5 years until next milestone

Study Start

First participant enrolled

October 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

March 30, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

March 26, 2020

Last Update Submit

March 27, 2020

Conditions

Neonatal Disorder

Keywords

NeonatalSurgeryNeonatal surgery

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

    Validated structured survey questionnaire will be circulated through SurveyMonkey

    1 day (Once through cross-sectional survey)

Interventions

Neonatal surgeriesPROCEDURE

Current practices of neonatal surgeries in India

Eligibility Criteria

Age26 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Neonatologists Pediatricians Neonatal and Pediatric surgeons

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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. No abstract available.

    PMID: 26023377BACKGROUND

  • 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.

    PMID: 31571756BACKGROUND

  • 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.

    PMID: 21180496BACKGROUND

  • 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.

    PMID: 30686886RESULT

Related Links

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Neha Sharma, MPT

    Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asir J Samuel, MPT, PhD

CONTACT

8059930222asirjohnsamuel@mmumullana.org

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 26, 2020

First Posted

March 30, 2020

Study Start

October 1, 2021

Primary Completion

October 31, 2022

Study Completion

March 20, 2023

Last Updated

March 30, 2020

Record last verified: 2020-03