Reno-protective Effect of Brain Cooling in Newborn With Hypoxia

NCT02683915 | Completed DMC

• 1 other identifier: MS-602
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic Ischemic Encephalopathy

Keywords

Acute kidney injury; Perinatal asphyxia; Therapeutic hypothermia; Serum NGAL; Serum cystatin-C

Outcome Measures

Primary Outcomes (1)

• Acute kidney injury

  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

  15 days

Study Arms (2)

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

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.

Interventions

Therapeutic hypothermia PROCEDURE

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).

Also known as: Cooling

Therapeutic hypothermia

Eligibility Criteria

• Age: 30 Minutes - 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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).

You may qualify if:

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

You may not qualify if:

• Major intracranial haemorrhage
• Birth weight less than 1800 g.
• Major congenital anomalies including:
• Chromosomal anomalies.
• Congenital heart disease.
• Congenital diaphragmatic hernia.
• Congenital hydrocephalus and neural tube defects.
• Intestinal atresia, tracheooesophageal fistulas, and omphalocele.

Sponsors & Collaborators

• Mansoura University Children Hospital: lead

Study Sites (1)

Mansoura University Children Hospital

Al Mansurah, El Dakahlya, 35111, Egypt

Location

Related Publications (1)

• Nour I, Elmaghraby R, Shehata R, El-Refaey A, Aldomiaty H, Mosbah A, Shouman B, Nasef N. Selective head cooling and acute kidney injury in neonates with hypoxic ischemic encephalopathy. J Neonatal Perinatal Med. 2020;13(1):21-30. doi: 10.3233/NPM-180200.

  PMID: 31561395 DERIVED

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Acute Kidney Injury

Interventions

Hypothermia, Induced; Cool-Down Exercise

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cryotherapy; Therapeutics; Post-Exercise Recovery Techniques; Physical Therapy Modalities; Rehabilitation; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of pediatrics

Study Record Dates

• First Submitted: February 3, 2016
• First Posted: February 17, 2016
• Study Start: September 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: April 3, 2018

Record last verified: 2018-04

Locations

EG (1)