Neonatal DisorderNCT04326361
A Survey of Neonatal Surgery Practices in India
An observational study of Neonatal Disorder, run by Maharishi Markendeswar University (Deemed to be University).
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. Read more about this study
- Who is it for?
- Ages 26 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Neonatal Disorder
- What is being tested?
- Neonatal surgeries
- Type of treatment
- Surgery or procedure
- How many people
- 930 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2021to 20 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 26 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Neonatologists Pediatricians Neonatal and Pediatric surgeons
Who may be able to join
- 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.
Who cannot join
- Undergraduate Bachelor of medicine and Bachelor of Surgery (MBBS) students,
- students who are not willing to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Neonatal Surgeries in India: A Nationwide Survey Among Neonatal and Pediatric Specialists
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.
Read the detailed 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.
- Conditions
- Neonatal Disorder
- Being tested
- Neonatal surgeries
- Keywords
- Neonatal, Surgery, Neonatal surgery
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neonatal surgeriesProcedure or surgery
Current practices of neonatal surgeries in India
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Validated structured survey questionnaire will be circulated through SurveyMonkey
Measured: 1 day (Once through cross-sectional survey)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Oct 2021 (estimated)
- Primary completion31 Oct 2022 (estimated)
- Study completion20 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 930 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asir John Samuel, Maharishi Markendeswar University (Deemed to be University)
- Investigators
- Neha Sharma, MPT, Principal investigator, Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326361
- Sponsor's protocol ID
- MMDU/IEC/109P
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Publications
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.
PubMed 26023377Siddharth 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.
PubMed 31571756Lin 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.
PubMed 21180496Puri 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.
PubMed 30686886
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neonatal Surgeries in India: A Nationwide Survey Among Neonatal and Pediatric Specialists
- ClinicalTrials.gov ID
- NCT04326361
- Acronym / sponsor ID
- MMDU/IEC/109P
- Conditions
- Neonatal Disorder
- Keywords
- Neonatal, Surgery, Neonatal surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 930 participants (estimated)
- Lead sponsor
- Maharishi Markendeswar University (Deemed to be University)University, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 20 Mar 2023 (estimated)
- First posted
- 30 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 26 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Neonatologists Pediatricians Neonatal and Pediatric surgeons
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Undergraduate Bachelor of medicine and Bachelor of Surgery (MBBS) students,
- students who are not willing to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neonatal surgeriesCurrent practices of neonatal surgeries in India | Procedure or surgery | – |
Primary outcome
Questionnaire
Time frame: 1 day (Once through cross-sectional survey)
Validated structured survey questionnaire will be circulated through SurveyMonkey
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 26023377Bhatnagar 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.
- Background: PubMed 31571756Siddharth 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.
- Background: PubMed 21180496Lin 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.
- Results publication: PubMed 30686886Puri 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.
- A Pilot Study on Neonatal Surgical Mortality: A Multivariable Analysis of Predictors of Mortality in a Resource-Limited Setting.Link provided by the sponsor.
- Current Trends in Neonatal Surgery in IndiaLink provided by the sponsor.
- Outcome of Care Provided in Neonatal Surgery Intensive Care Unit of a Public Sector Tertiary Care Teaching Hospital of India.Link provided by the sponsor.
- Minimally invasive surgery in neonates and infantsLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neha Sharma, MPT principal investigator
Maharishi Markandeshwar institute of Physiotherapy and Rehabilitation
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Disorder, run by Maharishi Markendeswar University (Deemed to be University).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asir J Samuel, MPT, PhD (8059930222, asirjohnsamuel@mmumullana.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 1 day (Once through cross-sectional survey)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04326361, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.