Actively Recruiting

Age: 2Hours - 28Days
All Genders
Healthy Volunteers
ID06533787

Impact of Echocardiography on Management of Critically Ill Neonates

Led by Sahar Abozkaly Mahmoud · Updated on 2025-06-03

50

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying critically ill neonates who show signs of hemodynamic instability to understand their outcomes, including mortality and illness severity. The study evaluates how echocardiography (heart ultrasound) can help manage these unstable newborns by tracking the time it takes for them to become stable again. This observational study compares unstable neonates to a control group of stable neonates to assess the impact of echocardiographic assessments. Neonates in the study receive detailed clinical examinations and echocardiographic assessments using a specialized device. Based on echocardiography results, treatments such as dobutamine, volume expansion, hydrocortisone, dopamine, epinephrine, or interventions for patent ductus arteriosus (PDA) may be given according to specific heart function findings. These procedures are repeated regularly, with daily echocardiographic follow-ups to monitor heart function and stability. Participants undergo continuous monitoring including clinical exams and repeated echocardiograms to evaluate heart function parameters like ejection fraction, ductus arteriosus condition, pulmonary hypertension, and cardiac indexes. These assessments occur daily or at set intervals to track progress. The study involves neonates from birth up to 28 days old, with care and data collection continuing until discharge to measure outcomes and safety throughout hospitalization.

CONDITIONS

Brief Title

Impact of Echocardiography on Management of Critically Ill Neonates

Who Can Participate

Age: 2Hours - 28Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Neonates aged 0 to 28 days admitted to the NICU with signs of hemodynamic instability or critical illness
  • Inclusion regardless of gestational age, weight, gender, or disease type
Not Eligible

You will not qualify if you...

  • Failure to obtain informed consent
  • Presence of congenital heart disease except for PDA, PFO, or small ASD only

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - Until discharge from the NICU

Participants are regularly monitored with clinical examinations and echocardiographic assessments to detect signs of hemodynamic instability or shock.

Daily echocardiographic assessments and clinical examinations

Long-term Monitoring

Duration - Up to 5 days after initial echocardiographic assessment

Participants continue to undergo repeated echocardiographic assessments to evaluate cardiac function and manage conditions such as pulmonary hypertension and PDA.

Repeated echocardiographic assessments daily with an additional assessment 5 days after the first

Trial Site Locations

Total: 1 location

1

Sohag University Hospital

Sohag, Egypt

Actively Recruiting

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Research Team

S

Sahar Abuzakaly Mahmoud, MBBS

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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