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Completed

NCT Number: NCT00873847

Cerebral Function Monitoring in Premature Infants

This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites.

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Key information

Conditions

Infant, Newborn Electroencephalography Female Urogenital Diseases and Pregnancy Complications Infant, Low Birth Weight Infant, Premature Infant, Small for Gestational Age Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University, Palo Alto, California, United States

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About this study

Few techniques exist to permit early and accurate prognosis of brain injury in newborns. Cranial ultrasound and magnetic resonance imaging (MRI) have been used to detect structural abnormalities which may be useful in predicting neuromotor and neurocognitive deficits. However, up to 30% of extremely low birth weight infants with normal ultrasounds have adverse outcomes, and MRI is not feasible when an infant is critically ill. Amplitude-integrated electroencephalogram (aEEG) is a non-invasive, bedside instrument which allows real-time monitoring of brain function and may provide additional information for predicting outcomes in extremely premature infants.

This observational study will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites. Eligible infants will undergo an aEEG recording in the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age.

The study tests the feasibility of enrolling subjects and obtaining the required aEEG recordings. The information gathered will provide a framework for the design of a potential prospective, observational, multi-center study for prediction of death or neurodevelopmental impairment by 18-22 months of age.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Inborn infants
  • Between 401 grams and 1,000 grams inclusive birth weight OR between 23 0/7 and 28 6/7 weeks inclusive gestational age
  • Decision to provide full intensive care support
  • Less than 72 hours of age

Exclusion criteria

  • Non-intact skin at the central or parietal regions of scalp
  • Presence of known or suspected congenital anomalies, including:
  • Congenital central nervous system malformations
  • Chromosomal anomalies or multiple congenital anomalies
  • Complex congenital heart disease
  • Inborn error of metabolism
  • Acidosis (pH < 6.8 for > 2 hours)
  • Persistent bradycardia [HR < 100 bpm] associated with hypoxia for > 2 hours

Treatment and study plan

Primary outcomes

  1. First aEEG within 72 hours of age

    Time frame: < 72 hours of age

Secondary outcomes

  1. Time required by research personnel to conduct study activities

    Time frame: Birth to 36 weeks post menstrual age

  2. Serious adverse events

    Time frame: < 72 hours of age until 36 weeks post menstrual age

  3. Agreement between aEEG recordings and clinical events including: seizures, cardiopulmonary resuscitation, surfactant administration, suctioning, and intubation

    Time frame: < 72 hours of age until 36 weeks post menstrual age

  4. Weekly aEEG until infant is 36 weeks post menstrual age

    Time frame: < 72 hours of age until 36 weeks post menstrual age

Sponsors and collaborators

Lead sponsor

NICHD Neonatal Research Network

Network

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Center for Research Resources (NCRR)

Registry information

Official study title

Cerebral Function Monitoring and Brain Injury in Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment - a Pilot Study

Important dates

Study start
2009
Primary completion
2010
Study completion
2012
First posted
Apr 2, 2009
Registry last updated
Sep 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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