Clinical Trial Details
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[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT02601339 : NIRS Monitoring in Premature Infants
PhaseN/A
AgesMin: N/A Max: 3 Months
Eligibility
1. GM-IVH group Inclusion criteria for GM-IVH group: born at gestational age (GA) 24-37
weeks; < 3 months old corrected age at first measure or eligible for measurement
within 12 weeks after the infant reaches 40 weeks post-menstrual age (PMA). Grade
I-IV IVH diagnosed by clinical cranial ultrasound.

Exclusion criteria for GM-IVH group: congenital brain malformation; genetic
disorders; severe chromosomal abnormality/syndrome; metabolic or structural
abnormality or neoplasm; congenital heart disease; congenital hydrocephalus; imaging
evidence of white matter abnormalities or brain lesions other than GM-IVH; infection.

2. PHH group Inclusion criteria for PHH group: born at gestational age (GA) 24-37 weeks;
< 3 months old corrected age at first measure or eligible for measurement within 12
weeks after the infant reaches 40 weeks age (PMA). PHH diagnosed by clinical cranial
ultrasound.

Exclusion criteria for PHH group: congenital brain malformation; genetic disorders;
severe chromosomal abnormality/syndrome; metabolic or structural abnormality or
neoplasm; congenital heart disease; congenital hydrocephalus; imaging evidence of
white matter abnormalities or brain lesions other than IVH-PHH; infection.

3. HC group Inclusion criteria for HC group: born at gestational age (GA) 24-37 weeks; <
3 months old corrected age at first measure or eligible for measurement within 12
weeks after the infant reaches 40 weeks age (PMA); Apgar >7 at 5 min.

Exclusion criteria for HC group: any clinical indication of brain injury or
congenital brain malformation; genetic disorders; severe chromosomal
abnormality/syndrome; known or suspected metabolic disorder or neoplasm; congenital
heart disease.

4. VC group Inclusion criteria for VC group: < 3 months old corrected age at first
measure or eligible for measurement within 12 weeks after the infant reaches 40 weeks
age (PMA). Symptomatic hydrocephalus of any etiology except post-hemorrhagic
etiology; characterized by abnormal rate of head growth and full anterior fontanelle.
Ventricular enlargement diagnosed by ultrasonography or MRI; no signs of IVH.

Exclusion criteria for VC group: known or suspected metabolic disorder or neoplasm;
congenital heart disease.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02601339      |      Link to official Clinicaltrials.gov listing
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