Follow-up Visit of High Risk Infants
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-26
SponsorNICHD Neonatal Research Network
About this trial
The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants inborn at NRN centers
<27 weeks gestational age
Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the above, inclusion and
Disqualifiers
None
Trial population
Infants born at 401-1000 grams birth weight and/or \<29 weeks gestational age
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No Intervention
Other interventionNo Intervention
Treatment groups
68,000 Participants
are divided into 1 treatment groupGroup A: Registry Cohort1 intervention
Trial outcomes
Primary outcomes
1
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner
Time frame
Longitudinal database currently funded through 3/31/2016Secondary outcomes
1
To examine the relationship between baseline characteristics and outcome
Time frame
Longitudinal database currently funded through 3/31/20162
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies
Time frame
Longitudinal database currently funded through 3/31/2016Sponsors and contacts
Click on the lead sponsor to view all of their trials.
NICHD Neonatal Research Network
Lead sponsor
National Center for Research Resources (NCRR)
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov