Cerebral Function Monitoring in Premature Infants

NCT00873847 | Completed DMC

• 9 other identifiers: NICHD-NRN-0042U10HD021373U10HD021385U10HD027851U10HD027880U10HD027904U10HD040492U10HD040689UL1RR025744
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Electroencephalography

Keywords

NICHD Neonatal Research Network; Very Low Birth Weight (VLBW); Extremely Low Birth Weight (ELBW); Prematurity; Amplitude-integrated Electroencephalography (aEEG)

Outcome Measures

Primary Outcomes (1)

• First aEEG within 72 hours of age

  < 72 hours of age

Secondary Outcomes (4)

• Time required by research personnel to conduct study activities

  Birth to 36 weeks post menstrual age

• Serious adverse events

  < 72 hours of age until 36 weeks post menstrual age

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

  < 72 hours of age until 36 weeks post menstrual age

• Weekly aEEG until infant is 36 weeks post menstrual age

  < 72 hours of age until 36 weeks post menstrual age

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants born at NRN centers and admitted to the NICU that are between 401 grams and 1,000 grams OR between 23 0/7 and 28 6/7 weeks gestational age. Infants must be enrolled by the time they are 72 hours old.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (8)

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

RTI International

Durham, North Carolina, 27705, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Davis AS, Gantz MG, Do B, Shankaran S, Hamrick SE, Kennedy KA, Tyson JE, Chalak LF, Laptook AR, Goldstein RF, Hintz SR, Das A, Higgins RD, Ball MB, Hale EC, Van Meurs KP; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Serial aEEG recordings in a cohort of extremely preterm infants: feasibility and safety. J Perinatol. 2015 May;35(5):373-8. doi: 10.1038/jp.2014.217. Epub 2014 Dec 4.

  PMID: 25474559 RESULT

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Abbot R. Laptook, MD

  Brown University, Women & Infants Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• Ricki F. Goldstein, MD

  Duke University

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Abhik Das, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Alexis Davis, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Lina Chalak, MD

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

• Kathleen A. Kennedy, MD MPH

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2009
• First Posted: April 2, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: August 1, 2012
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (8)