Generic Database of Moderate Preterm Infants

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01793116
First received: February 13, 2013
Last updated: September 26, 2013
Last verified: August 2013
  Purpose

This is a registry of moderate preterm infants, born alive at 29-33 weeks gestational age, in NICHD Neonatal Research Network (NRN) centers. The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.


Condition
Infant, Newborn
Infant, Moderate Preterm

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 11 Weeks
Official Title: Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 Weeks)

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Number of infants born moderately preterm [ Time Frame: up to 2 years ] [ Designated as safety issue: No ]
    Number of infants born between 29-33 weeks gestational age at 18 participating NRN centers.


Estimated Enrollment: 6000
Study Start Date: March 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The Moderate Preterm Registry is a registry of moderate preterm infants (29-33 weeks gestational age) born alive in NICHD Neonatal Research Network (NRN) centers. The purpose is to collect baseline and outcome data in a uniform manner on a cohort of infants.

The registry collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Baseline data is collected soon after admission to the NICU; outcome data is collected at the time of death or discharge from the hospital. The data collected includes information on:

  • Demographics of mother and infant
  • Mother's health (e.g., pregnancy history and complications)
  • Labor and deliver (e.g., rupture of the membranes, steroids and antibiotics given, mode of delivery)
  • Infant's health (gestational age, Apgar scores, weight, length, delivery room resuscitation, respiratory support, etc.)
  • Infant's medical outcome (heart, lung, nervous system, gastrointestinal system, hearing, and vision, known infections, and major malformations/syndromes, and mortality or number of days hospitalized).

These data are used: to examine associations between baseline characteristics, treatments, and outcomes; to track trends in incidences of disease and effectiveness of therapies; and to identify questions requiring additional in-depth research.

Informed Consent: As required by local IRBs.

  Eligibility

Ages Eligible for Study:   29 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Moderately preterm infants born at 29 0/7 weeks to 33 6/7 weeks—both inborn and outborn but admitted prior to 72 hours at NRN centers will be included in this study.

Criteria

Inclusion Criteria:

  • Gestational age 29-33 weeks
  • Inborn infants and outborn infants admitted by 72 hours.

Exclusion Criteria:

  • None
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01793116

Contacts
Contact: Michele C Walsh, MD, MS 216-844-3759
Contact: Rosemary D Higgins, MD 301-496-5575

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Waldemar A. Carlo, MD    205-934-4680    wcarlo@peds.uab.edu   
Contact: Monica V. Collins, RN BSN    (205) 934-5771    mcollins@peds.uab.edu   
Principal Investigator: Waldemar A. Carlo, MD         
United States, California
University of California - Los Angeles Recruiting
Los Angeles, California, United States, 90025
Contact: Uday Devaskar, MD    310-825-9357    udevaskar@mednet.ucla.edu   
Contact: Teresa Chanlaw, BS    (310) 794-4972    tchanlaw@mednet.ucla.edu   
Principal Investigator: Uday Devaskar, MD         
Stanford University Recruiting
Palo Alto, California, United States, 94304
Contact: Krisa P. Van Meurs, MD    650-723-5711    vanmeurs@leland.stanford.edu   
Contact: M. Bethany Ball, BS CCRC    (650) 725-8342    mbball@stanford.edu   
Principal Investigator: Krisa P. Van Meurs, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30303
Contact: Barbara J. Stoll, MD    404-727-5740    barbara_stoll@oz.ped.emory.edu   
Contact: Ellen Hale, RN BS    (404) 616-4218    ellen_hale@oz.ped.emory.edu   
Principal Investigator: Barbara J. Stoll, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Brenda B. Poindexter, MD MS    317-274-3592    bpoindex@iupui.edu   
Contact: Leslie D. Wilson, RN BSN    (317) 274-8255    ldw@iupui.edu   
Principal Investigator: Brenda B. Poindexter, MD MS         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Edward F. Bell, MD    319-356-4006    edward-bell@uiowa.edu   
Contact: Karen J. Johnson, RN BSN    (319) 356-2924    karen-johnson@uiowa.edu   
Principal Investigator: Edward F. Bell, MD         
United States, Michigan
Wayne State University Recruiting
Detroit, Michigan, United States, 48201
Contact: Seetha Shankaran, MD    313-580-4452    sshankar@med.wayne.edu   
Contact: Rebecca Bara, RN BSN    (313) 745-1436    rbara@med.wayne.edu   
Principal Investigator: Seetha Shankaran, MD         
United States, Missouri
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact: William Truog, MD    816-234-3592    wtruog@cmh.edu   
Contact: Cheri Gauldin, BSN    (816) 234-3920    cagauldin@cmh.edu   
Principal Investigator: William Truog, MD         
United States, New Mexico
University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131
Contact: Kristi L. Watterberg, MD    505-272-3967    kwatterberg@salud.unm.edu   
Contact: Conra Backstrom Lacy, RN    (505) 272-0367    cbackstrom@salud.unm.edu   
Principal Investigator: Kristi L. Watterberg, MD         
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Carl T D'Angio, MD    585-273-4911    carl_dangio@urmc.rochester.edu   
Contact: Holly Wadkins    585-275-0218    Holly_Wadkins@urmc.rochester.edu   
Principal Investigator: Carl T D'Angio, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Ronald N. Goldberg, MD    919-681-6025    goldb008@mc.duke.edu   
Contact: Gloria Siaw, BSN CRA    (919) 681-5859    gloria.siaw@duke.edu   
Principal Investigator: Ronald N. Goldberg, MD         
Sub-Investigator: C. Michael Cotten, MD MHS         
RTI International Active, not recruiting
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Kurt Schibler, MD    513-636-3972    kurt.schibler@cchmc.org   
Contact: Cathy Grisby, BSN CCRC    (513) 558-4953    grisbyca@email.uc.edu   
Principal Investigator: Kurt Schibler, MD         
Case Western Reserve University, Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact: Michele C. Walsh, MD MS    216-844-3759    mcw3@cwru.edu   
Contact: Nancy S. Newman, BA RN    (216) 368-3084    nxs5@cwru.edu   
Principal Investigator: Michele C. Walsh, MD MS         
Research Institute at Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Leif Nelin, MD    614-722-3030    Leif.Nelin@nationwidechildrens.org   
Contact: Patty Luzader, RN    614-355-6627    patty.luzader@nationwidechildrens.org   
Principal Investigator: Leif Nelin, MD         
United States, Pennsylvania
Univeristy of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Barbara Schmidt, MD    215-662-3228    barbara.schmidt@uphs.upenn.edu   
Contact: Aasma Chaudhary, BS    215-615-5442    aasma.chaudhary@uphs.upenn.edu   
Principal Investigator: Barbara Schmidt, MD         
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Abbot R. Laptook, MD    401-274-1122    alaptook@WIHRI.org   
Contact: Angelita Hensman    (401) 274-1122    ahensman@wihri.org   
Principal Investigator: Abbot R. Laptook, MD         
United States, Texas
University of Texas Southwestern Medical Center at Dallas Recruiting
Dallas, Texas, United States, 75235
Contact: Pablo J. Sanchez, MD    214-648-3753    Pablo.Sanchez@UTSouthwestern.edu   
Contact: Diana M. Vasil, RNC-NIC    (214) 648-3789    Diana.Vasil@utsouthwestern.edu   
Principal Investigator: Pablo J. Sanchez, MD         
University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Kathleen A. Kennedy, MD MPH    713-500-6708    Kathleen.A.Kennedy@uth.tmc.edu   
Contact: Georgia E. McDavid, RN    (713) 500-5734    Georgia.E.McDavid@uth.tmc.edu   
Principal Investigator: Kathleen A. Kennedy, MD MPH         
Sub-Investigator: Jon E. Tyson, MD MPH         
Sponsors and Collaborators
Investigators
Principal Investigator: Abbot R Laptook, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michele C Walsh, MD, MS Case Western Reserve University, Rainbow Babies and Children's Hospital
Principal Investigator: Ronald N Goldberg, MD Duke University
Principal Investigator: Barbara J Stoll, MD Emory University
Principal Investigator: Brenda B Poindexter, MD, MS Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: Krisa P Van Meurs, MD Stanford University
Principal Investigator: Kurt Schibler, MD Cincinnati Children's Medical Center
Principal Investigator: Waldemar Carlo, MD University of Alabama at Birmingha
Principal Investigator: Edward F Bell, MD University of Iowa
Principal Investigator: Kristi L Watterberg, MD University of New Mexico
Principal Investigator: Pablo J Sanchez, 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: William Truog, MD Abbot R Laptook, MD Study Principal Investigator Brown University, Women & Infants Hospital of Rhode Island Michele C Walsh, MD MS Study Principal Investigator Case Western Reserve University, Rainbow Babies and Children's Hospital Ronald N Goldberg,
Principal Investigator: Barbara Schmidt, MD, MSc University of Pennsylvania
Principal Investigator: Carl D'Angio, MD University of Rochester
Principal Investigator: Uday Devaskar, MD University of California, Los Angeles
Principal Investigator: Leif Nelin, MD Research Institute at Nationwide Children's Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01793116     History of Changes
Other Study ID Numbers: NICHD-NRN-0049, U10HD021364, U10HD040689, U10HD021385, U10HD027851, U10HD027853, U10HD027856, U10HD027904, U10HD027880, U10HD034216, U10HD021373, U10HD040492, U10HD053109, U10HD040461, U10HD068244, U10HD068263, U10HD068270, U10HD068278, U10HD068284, U10HD036790
Study First Received: February 13, 2013
Last Updated: September 26, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Moderately Preterm

ClinicalTrials.gov processed this record on September 18, 2014