In Utero Magnesium Sulfate Exposure: Effects on Extremely-Low-Birth-Weight Infants

NCT01203501 | Completed

• 25 other identifiers: NICHD-NRN-0016U10HD034216U10HD027904U10HD021364M01RR000080U10HD027853M01RR008084U10HD027851M01RR000039U10HD034167M01RR001032M01RR002635U10HD027856M01RR000750U10HD021397U10HD027881M01RR000997U10HD027880M01RR000070U10HD021415U10HD021373M01RR000633U10HD021385U10HD027871M01RR006022
• Study Type: observational
• Target: 1,339
• Locations: 1 country
• Sites: 15

Brief Summary

This study examined the effect of magnesium sulfate (MgSO4) exposure on adverse outcome in extremely low birth weight (ELBW) infants. For infants included in the NICHD Neonatal Research Network Generic Database whose mothers were given prenatal MgSO4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).

Conditions

Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Intracranial Hemorrhages; Leukomalacia, Periventricular; Cerebral Palsy

Keywords

NICHD Neonatal Research Network; Extremely Low Birth Weight (ELBW); Prematurity; Antenatal Magnesium sulfate

Outcome Measures

Primary Outcomes (1)

• Incidence of Intraventricular Hemorrhage

  Hospital discharge 120 days of life

Secondary Outcomes (1)

• Incidence of cerebral palsy

  18-22 months corrected age

Eligibility Criteria

• Age: Up to 14 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

All infants with birth weights 401 through 1500 grams admitted to the NICU within 14 days of age are eligible for the study. In addition, all inborn, liveborn infants in the same weight range (401-1500 gms) who die prior to admission to the NICU are enrolled posthumously.

You may qualify if:

• Infants born in NRN Centers with a birth weight of 401-1,500g

You may not qualify if:

• None

Sponsors & Collaborators

• NICHD Neonatal Research Network: lead
• National Center for Research Resources (NCRR): collaborator

Study Sites (15)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Yale University

New Haven, Connecticut, 06504, United States

Location

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30303, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Harvard University

Cambridge, Massachusetts, 02138, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Cincinnati Children's Medical Center

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University, Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Brown University, Women & Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

University of Tennessee

Memphis, Tennessee, 38163, United States

Location

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, 75235, United States

Location

Related Links

• NICHD Neonatal Research Network

MeSH Terms

Conditions

Premature Birth; Intracranial Hemorrhages; Leukomalacia, Periventricular; Cerebral Palsy

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Encephalomalacia; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic

Study Officials

• James A. Lemons, MD

  Indiana University

  STUDY DIRECTOR

• Waldemar A. Carlo, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• William Oh, MD

  Brown University, Womens and Infants Hospital

  PRINCIPAL INVESTIGATOR

• Avroy A. Fanaroff, MD

  Case Western Reserve University, Rainbow Babies & Children's Hospital

  PRINCIPAL INVESTIGATOR

• Edward F. Donovan, MD

  Children's Hospital Medical Center, Cincinnati

  PRINCIPAL INVESTIGATOR

• Barbara J. Stoll, MD

  Emory University

  PRINCIPAL INVESTIGATOR

• Ann R. Stark, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Charles R. Bauer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

• Lu-Ann Papile, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• David K. Stevenson, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Sheldon B. Korones, MD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Jon E. Tyson, MD MPH

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

• Seetha Shankaran, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

• Richard A. Ehrenkranz, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Raymond Bain, PhD

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: July 1, 1996
• Primary Completion: June 1, 1998
• Study Completion: June 1, 2000
• Last Updated: September 26, 2017

Record last verified: 2017-09

Locations

US (15)