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Status unknownNCT05312333Updated Apr 5, 2022

Holter Monitoring of Critically-ill Childern in PICU at Sohag University Hospital

An observational study in Critically Ill Childern in PICU, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Month to 12 Years. Per ClinicalTrials.gov, last updated 2022-04-05.

Sponsored by Sohag University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Enrollment
100
Ages
1 Month to 12 Years
Sex
All
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Study summary

Holter Monitoring is a way to continuously check the electrical activity of the heart .

Continuous ECG recording show to be one of the most effective noninvasive clinical tools in the diagnosis of cardiac symptoms prognostic assessment and in the evaluation of many cardiac therapeutic intervention.

The clinical utility of ambulatory ECG lies in its ability to examine continuously a patient over an extended period of time, permitting patient ambulatory activity and facilitating the diurnal electrocardiographic examination of a patient in a changing environmental conditions (both physical and psychological) .

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Conditions studied

  • Critically Ill Childern in PICU

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03

In context

Critical Illness

1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.

This study's planned enrollment of 100 is below the median of 130 across 867 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Critically ill children are those children whom requiring, or potentially requiring, high reliance or serious consideration.

There are variant emergent conditions may affect the child, such as airway problems which includes tonsillitis, airway obstruction which caused be foreign-body, pneumonia, asthma, and bronchitis, in addition to cardiac arrest and respiratory failure. There is also abdominal pain diarrhea, nausea, and vomiting. Child also may face seizures, poisoning sudden infant death syndrome (SIDS).

  • Having seizures; unusual movements.
  • No spontaneous development, unfit to sit or stand.
  • Less alert or drew in with clinician or parental figure; not resisting of the examination.
  • No interaction or eye-to-eye connection with individuals and the surrounding.

Eligibility criteria

Inclusion Criteria:

  • 1- children admitted to pediatric department as in :
  • Pediatric intensive care unit (PICU).
  • Pediatric critical care unit (PCCU).
  • Emergency room (ER). 2- Age from 1 month- 12 years. 3- Critical ill child fulfill these criteria:
  • Persistent convulsions.
  • Abnormal GCS
  • Haemodynamic instability
  • Foreign body inhalation
  • Sever cardiac problem
  • Irregular breathing
  • DKA
  • Others

Exclusion Criteria:1-Neonates 2-End-stage or those with end-organ failure . 3-Whom GCS is below 6. 4-Whom done cardiac catheterization for any purpose . 5-Previously done Holter. 6-Multiple traumatized patient.

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Study design

Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • critically-ill childern
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What researchers measure

Primary outcomes

  1. Abnormalities detecred in Holter monitoring of critically-ill childern

    the relation between abnormalities detected in Holter and prognosis of critically-ill childern

    Time frame: one year

  2. The relation between heart rate variability and outcome ,prognosis of illness

    Increased illness severity and poor outcomes ,the most common method of objectively assesing autonomic nervous system dysregulation is through measurement of heart rate variability ,which reflect the normal ,physiologic alternation in the intervals in the time between consecutive heart beats that occur when there is balance of sympathetic and parasympathetic inputs on the electrical conduction system of the heart.

    Time frame: one year

  3. Arrhythmia detected in critically-ill childern

    arrhythmia detected in Holter of critically ill childern whom have any critical illness

    Time frame: one year

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Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Kennedy HL. The history, science, and innovation of Holter technology. Ann Noninvasive Electrocardiol. 2006 Jan;11(1):85-94. doi: 10.1111/j.1542-474X.2006.00067.x. PubMed 16472287 ↗
  • Marsillio LE, Manghi T, Carroll MS, Balmert LC, Wainwright MS. Heart rate variability as a marker of recovery from critical illness in children. PLoS One. 2019 May 17;14(5):e0215930. doi: 10.1371/journal.pone.0215930. eCollection 2019. PubMed 31100075 ↗
  • Leteurtre S, Duhamel A, Salleron J, Grandbastien B, Lacroix J, Leclerc F; Groupe Francophone de Reanimation et d'Urgences Pediatriques (GFRUP). PELOD-2: an update of the PEdiatric logistic organ dysfunction score. Crit Care Med. 2013 Jul;41(7):1761-73. doi: 10.1097/CCM.0b013e31828a2bbd. PubMed 23685639 ↗
  • Rijnbeek PR, Witsenburg M, Schrama E, Hess J, Kors JA. New normal limits for the paediatric electrocardiogram. Eur Heart J. 2001 Apr;22(8):702-11. doi: 10.1053/euhj.2000.2399. PubMed 11286528 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05312333
Lead sponsor
Sohag University
Responsible party
Nourhan Ahmed Mohamed (resident doctor at pediateric department sohag university hospital, Sohag University) — Principal investigator
First posted
Apr 5, 2022
Start date
Mar 9, 2022
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Apr 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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