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Post-intervention for Gastroschisis

N/A
Waitlist Available
Led By Naomi J Wright, MBChB BSc MRCS DCH MSc
Research Sponsored by King's College London
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
all neonates presenting primarily to the study centre with simple gastroschisis regardless of weight, gestational age or co-morbidities.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during the 2-years of data collection including pre- and post-implementation phases of the study.
Awards & highlights

Study Summary

This study is a multi-centre interventional study at seven tertiary paediatric surgery centres in Ghana, Zambia, Malawi and Tanzania aimed at reducing mortality from gastroschisis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the 2-years of data collection including pre- and post-implementation phases of the study.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the 2-years of data collection including pre- and post-implementation phases of the study. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
All-cause, in-hospital mortality
Secondary outcome measures
Continuous Positive Airway Pressure
Length of hospital stay amongst survivors
Need for ventilation
+2 more
Other outcome measures
Implementation outcome: acceptibility [assessed using the validated 'Acceptability of Intervention Measure' (AIM) Survey]
Implementation outcome: adoption
Implementation outcome: appropriateness [assessed using the validated 'Intervention Appropriateness Measure' (IAM) Survey].
+11 more

Trial Design

2Treatment groups
Active Control
Group I: Pre-interventionActive Control1 Intervention
Patients presenting with simple gastroschisis during the pre-intervention phase will receive the current care provided by the study sites (no intervention).
Group II: Post-interventionActive Control2 Interventions
Patients presenting with simple gastroschisis during the post-implementation phase will receive the interventional care bundle if consent for participation is provided.

Find a Location

Who is running the clinical trial?

Arthur Davison Children's HospitalOTHER
2 Previous Clinical Trials
1,676 Total Patients Enrolled
University Teaching Hospital, Lusaka, ZambiaOTHER
19 Previous Clinical Trials
66,682 Total Patients Enrolled
1 Trials studying Gastroschisis
1,407 Patients Enrolled for Gastroschisis
Komfo Anokye Teaching HospitalOTHER
7 Previous Clinical Trials
5,319 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa
2018. "Multi-Centre Gastroschisis Interventional Study Across Sub-Saharan Africa". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03724214.
All > Sah
~36 spots leftby May 2025
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