Follow-up Visit of High Risk Infants

Recruiting

• Conditions: Infant, Premature; Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age

• Registration Number: NCT00009633
• Lead Sponsor: NICHD Neonatal Research Network

Brief Summary

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.

Detailed Description

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort study in which surviving extremely low birth-weight infants undergo neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 month corrected age). The goal of the study is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment, including:

* Evaluating development of motor skills, cognitive skills, language and behavior

* Determining mortality and the prevalence of specific medical conditions

* Assessing the relationship between growth and neurodevelopmental outcome

* Assessing the relationship between the socioeconomic status and developmental outcome

* Assessing the use of special support services and early intervention programs by this population

* Evaluating the need for follow-up at school age.

The scheduled evaluations collect: demographic information; socioeconomic status; medical history; medications; medical equipment required; growth data; a detailed neurologic examination; Bayley Scales of Infant Development (mental, motor, infant behavior); Child Behavior Checklist.

A sub-study will assess a reference group comprised of a limited number of healthy term infants born in Network centers to meet the following three aims: 1) to avoid potential ascertainment biases due to examiner expectations when only extremely preterm or other high-risk infants are assessed 2) in the absence of well-developed norms for the Bayley Scales, to define thresholds for impairment based on data for a representative sample of healthy children born at term in our centers and concurrently assessed by the same examiners as for our high-risk infants; and 3) to help identify and address when "drift" occurs over time in conducting and scoring Bayley assessments.

Study Timeline

• Study Start: 1993-04-01
• Study First Submitted: 2001-02-01
• Study First Submitted QC: 2001-02-02
• Study First Posted: 2001-02-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2030-03-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 68000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To maintain a registry of baseline and outcome data for VLBW infants with data collected in a uniform manner	Longitudinal database currently funded through 3/31/2016

Secondary Outcome Measures

Name	Time	Method
To provide data for hypothesis formulation and sample size calculation for Network multi-center studies	Longitudinal database currently funded through 3/31/2016
To examine the relationship between baseline characteristics and outcome	Longitudinal database currently funded through 3/31/2016

Trial Locations

Locations (31)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California - Los Angeles; 🇺🇸 Los Angeles, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of California at San Diego; 🇺🇸 San Diego, California, United States

Sharp Mary Birch Hospital for Women & Newborns; 🇺🇸 San Diego, California, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

George Washington University; 🇺🇸 Washington, District of Columbia, United States

University of Miami; 🇺🇸 Miami, Florida, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Northwestern Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States

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