NCT03882385

Brief Summary

The congenital malformation (CMF) include disturbance in normal process of organogenesis occurring before birth .

  • The (CMF) are structural ,functional, or (biochemical Molecular) defect presenting at birth.
  • The structural defect resulting from prenatal insult during period of embryogeneses.
  • The neonate with congenital malformation have differences in physiology, anatomy, in response to stress.
  • The (CMF) are important causes of infant disability , illness, deaths.
  • (CMF) classified into mild, moderate, severe and lethal

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
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

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 18, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

March 19, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2020

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

9 months

First QC Date

March 18, 2019

Last Update Submit

March 19, 2019

Conditions

Congenital Anomaly

Outcome Measures

Primary Outcomes (1)

  • detect number of total babies and percentages of congenital anomalies

    24 hours

Eligibility Criteria

Age1 Day - 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

study on neonates born with critical congenital anomalies that need intervention in NICU need resuscitation or refere to other specialist

You may qualify if:

  • Cases need resustation and stabilization.
  • Congenital anomalies that need admission in NICU eg: impeforated anus , meningiocele, heart disease, tacho osphageal fistula, urinary problems, diaphragmatic hernia, intestinal obstruction, duedodnal obstruction, neural tube defect .

You may not qualify if:

  • All vitally stable cases that don't need NICU admission and all cases not need immediate intervention of congenital anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bassil KL, Collier S, Mirea L, Yang J, Seshia MM, Shah PS, Lee SK; Canadian Neonatal Network. Association between congenital anomalies and area-level deprivation among infants in neonatal intensive care units. Am J Perinatol. 2013 Mar;30(3):225-32. doi: 10.1055/s-0032-1323584. Epub 2012 Aug 9.

    PMID: 22879358BACKGROUND

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Amira tharwat helmy, student

CONTACT

01206119729totonono744@gmail.com

amal ismael, professor dr

CONTACT

01067700334

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 20, 2019

Study Start

March 19, 2019

Primary Completion

November 30, 2019

Study Completion

November 29, 2020

Last Updated

March 21, 2019

Record last verified: 2019-03