The Long-term Neurodevelopmental Outcome After Intraventricular Hemorrhage (IVH)-Grades I-II in Preterm Infants at Ages 1-7 Years

NCT01912703 | Unknown DMC

• 1 other identifier: HYMC-297-13
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

It is well-known that preterm delivery can be accompanied by complications. One of these complications is Intraventricular Hemorrhage (IVH). There are four degrees of IVH, according to severity. It is known that IVH Grades 3-4 can cause severe neurodevelopmental outcomes, including cerebral palsy (CP), hemiplegia, lower motor and cognitive skills and social difficulties. It is not known whether IVH Grades I-II have any of these effects and the aim of this study is to determine whether they do have any neurodevelopmental outcomes.

Conditions

Premature Infants

Outcome Measures

Primary Outcomes (1)

• General Neurodevelopmental Assessment

  Retrospective study of preterm infants born in the years 2007-2011 and suffered IVH Grades 1-2 who have undergone a general neurodevelopmental assessment in the Institute for Child Development in Hillel Yaffe Medical Center at ages 1-7. This assessment will indicate whether IVH Grades 1-2 has any neurodevelopmental effect on these children.

  Seven years

Study Arms (2)

Preterm infants with IVH Grades I-II

Preterm infants (post-menstrual age 24-35 weeks) who were diagnosed with IVH Grades 1-2 in the neonatal intensive care unit (NICU).

Other: Telephone interview

Control Group

Preterm infants (post-menstrual age 24-35 weeks) who had no imaging evidence of IVH in the neonatal intensive care unit (NICU).

Other: Telephone interview

Interventions

Telephone interview OTHER

Subjects with incomplete data will be asked to complete a telephone interview

Control Group; Preterm infants with IVH Grades I-II

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants born in 2007-2011 at the Hillel Yaffe Medical Center

You may qualify if:

• All preterm infants born at 35 weeks or less
• Underwent at least 1 brain ultrasound
• Diagnosed with IVH Grades 1-2
• Had no other severe illness in NICU
• Had neurodevelopmental follow-up

You may not qualify if:

• All others

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Roei Abramovitch, MD

CONTACT

972-50-3205548; roeiabra@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: July 31, 2013
• Study Start: December 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 31, 2013

Record last verified: 2013-07

Locations

IL (1)