Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT00009633
Study type Observational
Source NICHD Neonatal Research Network
Contact Susan R Hintz, MD, MS Epi
Email srhintz@stanford.edu
Status Recruiting
Phase
Start date January 1993
Completion date March 31, 2030

See also
  Status Clinical Trial Phase
Completed NCT03146351 - The Effects of Family Centered Intervention Program on Preterm Infants N/A
Completed NCT02064712 - Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates N/A
Completed NCT00365703 - Nasogastric Tube vs. Orogastric Feeding Tube in Preterm Infants: Which is Best? N/A
Terminated NCT00179933 - The Impact of Implementing NIDCAP on Preterm Infants in the NICU N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Terminated NCT05030012 - Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants N/A
Completed NCT00552383 - The Edmonton Randomised Controlled Trial of NIDCAP - Based Developmental Care N/A
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Completed NCT06308471 - Effect of Baby Massage on Oral Motor Skills of Premature Babies N/A
Completed NCT01863043 - Aspiration of Residual Gastric Contents N/A
Completed NCT05462509 - Feasibility of Use of the PATH bCPAP and Oxygen Blenders Device With Neonates in Uganda N/A
Not yet recruiting NCT06109350 - The Effect of Physical Therapy Intervention on Motor Performance in Bhutanese Preterm Infants N/A
Terminated NCT02599545 - Testosterone and Cortisol Levels in Infants
Completed NCT03551600 - Splanchnic and Renal Tissue Oxygenation During Enteral Feedings in Neonates With Patent Ductus Arteriosus
Completed NCT02611284 - Less Invasive Beractant Administration in Preterm Infants N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT00455169 - Influenza Vaccine in Premature Infants Phase 4
Withdrawn NCT00536445 - Use of NAVA in Intubated Preterm Phase 1/Phase 2
Completed NCT00579553 - Comparing IM vs. Vaginal Progesterone for Pre-term Birth N/A
Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study