Neonatal DisorderNCT03691233
Diagnosis and Management of Neonatal Shock
An observational study of Neonatal Disorder, run by Assiut University.
Trial summary
The aim of this clinical audit is to assess the degree of adherence of medical physicians in Assiut university children hospital protocol for diagnosis and management of neonatal shock to the international guidelines. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Neonatal Disorder
- What is being tested?
- Clinical audit on diagnosis and management of neonatal shock
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 30 Dec 2019
- 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 1 minute to 28 days
- All sexes
- No healthy volunteers
- Child
Study population: The neonates who are admitted to neonatology Unit at Assiut University Children Hospital through this period
Who may be able to join
- All neonates (preterm or full term) who are developing shock
Who cannot join
- Neonates with multiple congenital anomalies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Audit on Diagnosis and Management of Neonatal Shock
The aim of this clinical audit is to assess the degree of adherence of medical physicians in Assiut university children hospital protocol for diagnosis and management of neonatal shock to the international guidelines.
Read the detailed description
Introduction Shock is defined as a state of impaired cellular energy (ATP) synthesis when tissue oxygen delivery no longer satisfies tissue oxygen demand (Kleinman etal., 2012)
Shock is an independent predictor of early neonatal mortality and more often a problem in preterm infants than in term infants, even late preterm infants are at much higher risk (Femitha and Bhat, 2012)
In the first phase of shock, perfusion and oxygen delivery is maintained towards the so-called vital organs (heart, brain, and adrenal glands) by selective regional vasodilation in combination with vasoconstriction to non-essential tissues, such as muscles, skin, kidneys, and the splanchnic tissues. This is the compensated stage of shock. As the product of cardiac output (which falls) and systemic vascular resistance (which increases), blood pressure actually remains in the normal range in a compensated shock. When this redistribution fails, perfusion and oxygenation of the vital organs will become impaired, resulting in multi-organ dysfunction. In this phase of uncompensated shock, systemic hypotension might be expected (Willem etal., 2018)
Echocardiography is one of the emerging technologies that can be used to measure cardiac output in critically ill newborn infants, especially since the clinical estimation of cardiac output is rather inaccurate (de Boode, 2010)
Diagnosis of Shock
The clinical diagnosis of shock in the early compensated phase often depends on assessment of peripheral perfusion,pulse volume, heart rate changes, metabolic acidosis and urine output.
Ideally, shock should be diagnosed at this stage. In the later uncompensated phase, blood pressure (BP) becomes a key parameter for monitoring and for titrating inotropes and fluids Willem etal.,2018). )
Clinicians rely on BP measurements to diagnose hypotension and to titrate therapy. Hypotension in preterm infants has been associated with an increased risk of intraventricular hemorrhage (Vishnu and Plakkal, 2015)
Treatment of Shock:
- Volume Expanders It is common practice to give one or two normal saline boluses when neonates present in shock, before assessing the need for inotropes. Apart from saline, albumin or other colloids are also sometimes used for volume expansion.
- Drug Therapy of Neonatal Shock
Dopamine is an endogenous catecholamine and has been shown to raise the blood pressure in hypotensive infants better than either albumin or dobutamine (Osborn and Evan, 2005) Cardiac arrhythmias And extravasation injury are potential adverse effects (Osborn etal., 2004)
Dobutamine, unlike dopamine, does not have endocrine effects and does not depend on the release of endogenous catecholamines for effect. It is predominantly inotropic, with some vasodilator effects, Indeed, there is some evidence that dobutamine is better than dopamine at increasing and maintaining systemic blood flow in preterm infants with low systemicblood flow (Subhedar and Shaw, 2003).
Epinephrine is usually used when shock is refractory to dopamine and dobutamine, although some use it as a first line drug, especially when septic shock is suspected (Maria etal., 2004)
Norepinephrine use in neonates is uncommon due to its vasoconstrictive effects, resulting in organ hypoperfusion and increased myocardial work (Pierre etal., 2008)
Hydrocortisone is most commonly used in catecholamine resistant shock in treatment of hypotension in very low birth weight infants (vishnu and plakkal, 2015). Hyperglycemia can be a troublesome short-term side effect (Ng etal., 2006)
Vasopressin is a potent vasoconstrictor and useful in vasodilatory shock (Brierley etal., 2009).
Supportive Treatment:
Pulmonary Support. Most neonates with shock requiring inotropic support will also require mechanical ventilation.(especially <28 wk) (Saugstad and Aune, 2014].
Antibiotics.
- Empirical antibiotics should be chosen based on prevailing infection patterns in each NICU (Adrienne etal., 2003)
Newer Developments in the Management of Neonatal Shock
Milrinone and amrinone are phosphodiesterase III inhibitors. they are vasodilators, hypotension can result. However, they are excellent inotropes and can also reduce pulmonary pressures (Nick etal., 2009)
Levosimendan is a newer drug which causes vasodilatation and improves calcium coupling to troponin, resulting in an increase in myocardial contractility (Papoff etal., 2012)
- Conditions
- Neonatal Disorder
- Being tested
- Clinical audit on diagnosis and management of neonatal shock
- 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.
Clinical audit on diagnosis and management of neonatal shockDrug
Also called fliuds
intervenous
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of healthcare providers by evaluating how much diagnosis and management of neonatal shock adherent to Assuit University Children Hospital guidelines.
analysis of results and compare them to guidelines
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion30 Oct 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Neonatal DisorderStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walaa Ahmed Ezzat Sadak, Assiut University
- Investigators
- Safwat M Abd Al-ziz, lecture, Principal investigator, Safwatabdelaziz371@yahoo.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03691233
- Sponsor's protocol ID
- neonatal shock
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 1 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bhat BV, Plakkal N. Management of Shock in Neonates. Indian J Pediatr. 2015 Oct;82(10):923-9. doi: 10.1007/s12098-015-1758-7. Epub 2015 May 21.
PubMed 25990594de Boode WP, van der Lee R, Horsberg Eriksen B, Nestaas E, Dempsey E, Singh Y, Austin T, El-Khuffash A; European Special Interest Group 'Neonatologist Performed Echocardiography' (NPE). The role of Neonatologist Performed Echocardiography in the assessment and management of neonatal shock. Pediatr Res. 2018 Jul;84(Suppl 1):57-67. doi: 10.1038/s41390-018-0081-1.
PubMed 30072807Osborn DA, Evans N. Early volume expansion versus inotrope for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2001;2001(2):CD002056. doi: 10.1002/14651858.CD002056.
PubMed 11406028Ng PC, Lee CH, Bnur FL, Chan IH, Lee AW, Wong E, Chan HB, Lam CW, Lee BS, Fok TF. A double-blind, randomized, controlled study of a "stress dose" of hydrocortisone for rescue treatment of refractory hypotension in preterm infants. Pediatrics. 2006 Feb;117(2):367-75. doi: 10.1542/peds.2005-0869.
PubMed 16452355Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.
PubMed 22161578Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology. 2014;105(1):55-63. doi: 10.1159/000356561. Epub 2013 Nov 15.
PubMed 24247112Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6.
PubMed 19325359Osborn DA, Evans N. Early volume expansion for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2004;2004(2):CD002055. doi: 10.1002/14651858.CD002055.pub2.
PubMed 15106166Subhedar NV, Shaw NJ. Dopamine versus dobutamine for hypotensive preterm infants. Cochrane Database Syst Rev. 2003;(3):CD001242. doi: 10.1002/14651858.CD001242.
PubMed 12917901
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit on Diagnosis and Management of Neonatal Shock
- ClinicalTrials.gov ID
- NCT03691233
- Acronym / sponsor ID
- neonatal shock
- Conditions
- Neonatal Disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 30 Oct 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 1 Oct 2018 (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 aim of this clinical audit is to assess the degree of adherence of medical physicians in Assiut university children hospital protocol for diagnosis and management of neonatal shock to the international guidelines.
Detailed description
Introduction Shock is defined as a state of impaired cellular energy (ATP) synthesis when tissue oxygen delivery no longer satisfies tissue oxygen demand (Kleinman etal., 2012)
Shock is an independent predictor of early neonatal mortality and more often a problem in preterm infants than in term infants, even late preterm infants are at much higher risk (Femitha and Bhat, 2012)
In the first phase of shock, perfusion and oxygen delivery is maintained towards the so-called vital organs (heart, brain, and adrenal glands) by selective regional vasodilation in combination with vasoconstriction to non-essential tissues, such as muscles, skin, kidneys, and the splanchnic tissues. This is the compensated stage of shock. As the product of cardiac output (which falls) and systemic vascular resistance (which increases), blood pressure actually remains in the normal range in a compensated shock. When this redistribution fails, perfusion and oxygenation of the vital organs will become impaired, resulting in multi-organ dysfunction. In this phase of uncompensated shock, systemic hypotension might be expected (Willem etal., 2018)
Echocardiography is one of the emerging technologies that can be used to measure cardiac output in critically ill newborn infants, especially since the clinical estimation of cardiac output is rather inaccurate (de Boode, 2010)
Diagnosis of Shock
The clinical diagnosis of shock in the early compensated phase often depends on assessment of peripheral perfusion,pulse volume, heart rate changes, metabolic acidosis and urine output.
Ideally, shock should be diagnosed at this stage. In the later uncompensated phase, blood pressure (BP) becomes a key parameter for monitoring and for titrating inotropes and fluids Willem etal.,2018). )
Clinicians rely on BP measurements to diagnose hypotension and to titrate therapy. Hypotension in preterm infants has been associated with an increased risk of intraventricular hemorrhage (Vishnu and Plakkal, 2015)
Treatment of Shock:
- Volume Expanders It is common practice to give one or two normal saline boluses when neonates present in shock, before assessing the need for inotropes. Apart from saline, albumin or other colloids are also sometimes used for volume expansion.
- Drug Therapy of Neonatal Shock
Dopamine is an endogenous catecholamine and has been shown to raise the blood pressure in hypotensive infants better than either albumin or dobutamine (Osborn and Evan, 2005) Cardiac arrhythmias And extravasation injury are potential adverse effects (Osborn etal., 2004)
Dobutamine, unlike dopamine, does not have endocrine effects and does not depend on the release of endogenous catecholamines for effect. It is predominantly inotropic, with some vasodilator effects, Indeed, there is some evidence that dobutamine is better than dopamine at increasing and maintaining systemic blood flow in preterm infants with low systemicblood flow (Subhedar and Shaw, 2003).
Epinephrine is usually used when shock is refractory to dopamine and dobutamine, although some use it as a first line drug, especially when septic shock is suspected (Maria etal., 2004)
Norepinephrine use in neonates is uncommon due to its vasoconstrictive effects, resulting in organ hypoperfusion and increased myocardial work (Pierre etal., 2008)
Hydrocortisone is most commonly used in catecholamine resistant shock in treatment of hypotension in very low birth weight infants (vishnu and plakkal, 2015). Hyperglycemia can be a troublesome short-term side effect (Ng etal., 2006)
Vasopressin is a potent vasoconstrictor and useful in vasodilatory shock (Brierley etal., 2009).
Supportive Treatment:
Pulmonary Support. Most neonates with shock requiring inotropic support will also require mechanical ventilation.(especially <28 wk) (Saugstad and Aune, 2014].
Antibiotics.
- Empirical antibiotics should be chosen based on prevailing infection patterns in each NICU (Adrienne etal., 2003)
Newer Developments in the Management of Neonatal Shock
Milrinone and amrinone are phosphodiesterase III inhibitors. they are vasodilators, hypotension can result. However, they are excellent inotropes and can also reduce pulmonary pressures (Nick etal., 2009)
Levosimendan is a newer drug which causes vasodilatation and improves calcium coupling to troponin, resulting in an increase in myocardial contractility (Papoff etal., 2012)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The neonates who are admitted to neonatology Unit at Assiut University Children Hospital through this period
Key inclusion criteria (1 listed)
- All neonates (preterm or full term) who are developing shock
Key exclusion criteria (1 listed)
- Neonates with multiple congenital anomalies
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 |
|---|---|---|
| Clinical audit on diagnosis and management of neonatal shockAlso: fliudsintervenous | Drug | – |
Primary outcome
Evaluation of healthcare providers by evaluating how much diagnosis and management of neonatal shock adherent to Assuit University Children Hospital guidelines.
Time frame: Baseline
analysis of results and compare them to guidelines
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2018.
- Background: PubMed 25990594Bhat BV, Plakkal N. Management of Shock in Neonates. Indian J Pediatr. 2015 Oct;82(10):923-9. doi: 10.1007/s12098-015-1758-7. Epub 2015 May 21.
- Background: PubMed 30072807de Boode WP, van der Lee R, Horsberg Eriksen B, Nestaas E, Dempsey E, Singh Y, Austin T, El-Khuffash A; European Special Interest Group 'Neonatologist Performed Echocardiography' (NPE). The role of Neonatologist Performed Echocardiography in the assessment and management of neonatal shock. Pediatr Res. 2018 Jul;84(Suppl 1):57-67. doi: 10.1038/s41390-018-0081-1.
- Background: PubMed 11406028Osborn DA, Evans N. Early volume expansion versus inotrope for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2001;2001(2):CD002056. doi: 10.1002/14651858.CD002056.
- Background: PubMed 16452355Ng PC, Lee CH, Bnur FL, Chan IH, Lee AW, Wong E, Chan HB, Lam CW, Lee BS, Fok TF. A double-blind, randomized, controlled study of a "stress dose" of hydrocortisone for rescue treatment of refractory hypotension in preterm infants. Pediatrics. 2006 Feb;117(2):367-75. doi: 10.1542/peds.2005-0869.
- Background: PubMed 22161578Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.
- Background: PubMed 24247112Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology. 2014;105(1):55-63. doi: 10.1159/000356561. Epub 2013 Nov 15.
- Background: PubMed 19325359Brierley J, Carcillo JA, Choong K, Cornell T, Decaen A, Deymann A, Doctor A, Davis A, Duff J, Dugas MA, Duncan A, Evans B, Feldman J, Felmet K, Fisher G, Frankel L, Jeffries H, Greenwald B, Gutierrez J, Hall M, Han YY, Hanson J, Hazelzet J, Hernan L, Kiff J, Kissoon N, Kon A, Irazuzta J, Lin J, Lorts A, Mariscalco M, Mehta R, Nadel S, Nguyen T, Nicholson C, Peters M, Okhuysen-Cawley R, Poulton T, Relves M, Rodriguez A, Rozenfeld R, Schnitzler E, Shanley T, Kache S, Skippen P, Torres A, von Dessauer B, Weingarten J, Yeh T, Zaritsky A, Stojadinovic B, Zimmerman J, Zuckerberg A. Clinical practice parameters for hemodynamic support of pediatric and neonatal septic shock: 2007 update from the American College of Critical Care Medicine. Crit Care Med. 2009 Feb;37(2):666-88. doi: 10.1097/CCM.0b013e31819323c6.
- Background: PubMed 15106166Osborn DA, Evans N. Early volume expansion for prevention of morbidity and mortality in very preterm infants. Cochrane Database Syst Rev. 2004;2004(2):CD002055. doi: 10.1002/14651858.CD002055.pub2.
- Background: PubMed 12917901Subhedar NV, Shaw NJ. Dopamine versus dobutamine for hypotensive preterm infants. Cochrane Database Syst Rev. 2003;(3):CD001242. doi: 10.1002/14651858.CD001242.
- pupmedLink provided by the sponsor.
- pupmedLink provided by the sponsor.
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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.
Safwat M Abd Al-ziz, lecture principal investigator
Safwatabdelaziz371@yahoo.com
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Disorder, run by Assiut 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 1 inclusion and 1 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 1 Oct 2018. 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 Nagwa Ali Mohamed, professer (01096260950, Namma65@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of healthcare providers by evaluating how much diagnosis and management of neonatal shock adherent to Assuit University Children Hospital guidelines. (time frame: Baseline). 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 NCT03691233, which also lists 9 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 1 Oct 2018.