Status:
UNKNOWN
Adolescents Born Preterm; Nurtured Beginnings
Lead Sponsor:
Boston Children's Hospital
Conditions:
Preterm Birth
Eligibility:
All Genders
14-18 years
Phase:
NA
Brief Summary
This research study is a long-term follow-up to an earlier study of developmental care. For that study, high risk preterm newborns were randomly assigned to a standard care group, which received the s...
Detailed Description
The study will test continued long-term intervention effectiveness into adolescence of very early born US preterm infants, who participated in a randomized Newborn Individualized Developmental Care an...
Eligibility Criteria
Inclusion
- Inclusion Criteria (when recruited as newborns):
- Gestational age at birth ≤ 28 weeks
- Birth weight ≤ 1250 grams
- In need of mechanical ventilation for at least 24 of the first 48 hours
- Singleton
- Born at the study hospital
- Free of known genetic or acquired infections or abnormalities
- Mother living in the vicinity of the study hospital
- Mother comfortable with English
- Mother free of major physical and mental illnesses
- Exclusion Criteria (when recruited as newborns):
- Gestational age at birth \> 28 weeks
- Birth weight \> 1250 grams
- No mechanical ventilation for the first 48 hours
- Multiple (twin, triplet)
- Not born at the study hospital
- Genetic or acquired infections or abnormalities
- Mother lived outside the vicinity of the study hospital
- Mother was not comfortable with English
- Mother had major physical and/or mental illnesses
Exclusion
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00310869
Start Date
January 1 2005
End Date
December 1 2019
Last Update
June 28 2017
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115