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Trial record 2 of 18 for:    cooling and premature

Reno-protective Effect of Brain Cooling in Newborn With Hypoxia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02683915
Recruitment Status : Completed
First Posted : February 17, 2016
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Nehad Nasef, Mansoura University Children Hospital

Brief Summary:
This study aims to determine the effect of therapeutic hypothermia on reducing AKI in term and late-preterm infants with hypoxic ischemic encephalopathy as estimated by measurment of serum(s) neutrophil gelatinase-associated lipocalin(NGAL) and serum (s) cystatin-C.

Condition or disease Intervention/treatment
Hypoxic Ischemic Encephalopathy Procedure: Therapeutic hypothermia

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Acute Kidney Injury in Asphyxiated Infants Treated by Therapeutic Hypothermia
Study Start Date : September 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Group/Cohort Intervention/treatment
Therapeutic hypothermia
Infants in cooled group will be fitted a cooling cap (Olympic Medical Cool Care System, Olympic Medical) around the head for 72 h. infants will be nursed under a radiant overhead heater, which is servo-controlled to the infant's abdominal skin temperature and adjusted to maintain the rectal temperature at 33.5-34.5ºC. At the end of the 72 h cooling period, the infants will be slowly rewarmed at no more than 0•5ºC /h until their temperature become within normal temperature range (36.5-37.5ºC).
Procedure: Therapeutic hypothermia
Infants in cooled group will be fitted a cooling cap (Olympic Medical Cool Care System, Olympic Medical) around the head for 72 h. infants will be nursed under a radiant overhead heater, which is servo-controlled to the infant's abdominal skin temperature and adjusted to maintain the rectal temperature at 33.5-34.5ºC. At the end of the 72 h cooling period, the infants will be slowly rewarmed at no more than 0•5ºC /h until their temperature become within normal temperature range (36.5-37.5ºC).
Other Name: Cooling

Non-cooled group
Infants in the non-cooled group received the current standard of care and will be placed under radiant heaters or in incubators, which are servo-controlled according to the abdominal skin temperature to maintain the rectal temperature at 37.0± 0.2°C.



Primary Outcome Measures :
  1. Acute kidney injury [ Time Frame: 15 days ]

    A serum createnine-based modification of the Acute Kidney Injury Network criteria:

    Stage 0: No change in SCr, Stage 1:↑SCr 0.3 mg/dL or ↑SCr 150- <200% from previous trough value, Stage 2: ↑ SCr 200- <300% from previous trough value, Stage 3: ↑ SCr ≥300% from previous trough value, SCr 2.5 mg/dL, or dialysis




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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Infants will be enrolled into two groups either group 1(cooled group) if identified within 12 hours of age and admitted at hospital with a validated cooling facility or group 2(non cooled group) if identified older than 12 hours of age or admitted at hospital out of reach of a validated cooling facility (cooling still not governmentally submitted in Egypt at wide scale).
Criteria

Inclusion criteria:

  1. Full term newborn exposed to peri-natal asphyxia
  2. Presented by signs of hypoxic ischemic encephalopathy (Sarnat grade II or III)

Exclusion criteria:

  1. Major intracranial haemorrhage
  2. Birth weight less than 1800 g.
  3. Major congenital anomalies including:

    1. Chromosomal anomalies.
    2. Congenital heart disease.
    3. Congenital diaphragmatic hernia.
    4. Congenital hydrocephalus and neural tube defects.
    5. Intestinal atresia, tracheooesophageal fistulas, and omphalocele.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02683915


Locations
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Egypt
Mansoura University Children Hospital
Mansoura, El Dakahlya, Egypt, 35111
Sponsors and Collaborators
Mansoura University Children Hospital
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Responsible Party: Nehad Nasef, Assistant Professor of pediatrics, Mansoura University Children Hospital
ClinicalTrials.gov Identifier: NCT02683915    
Other Study ID Numbers: MS-602
First Posted: February 17, 2016    Key Record Dates
Last Update Posted: April 3, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Nehad Nasef, Mansoura University Children Hospital:
Acute kidney injury
Perinatal asphyxia
Therapeutic hypothermia
Serum NGAL
Serum cystatin-C
Additional relevant MeSH terms:
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Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain