A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways
Family-centered intervention program
+ Usual care intervention program
Urogenital Diseases+3
+ Female Urogenital Diseases and Pregnancy Complications
+ Obstetric Labor Complications
Prevention Study
Summary
Study start date: May 22, 2012
Actual date on which the first participant was enrolled.A total of 275 VLBW preterm infants (269 participants and 6 pilots) were recruited at three medical centers in northern and southern Taiwan and were randomly assigned to the FCIP or UCP group. Outcome assessments included primary (neurobehavioral development) and secondary measures (neurophysiological performance, parents' stress and transactions within the family). The neurophysiological and transactions data were examined for whether they mediate intervention effects on child development. In addition, these infants 219 VLBW preterm infants and 118 term infants in our prior intervention studies were collected buccal cells for assessment of the polymorphisms of dopamine-related genes, which are involved in the neurotransmission of cognitive, sensorimotor and behavioral-emotional systems and postulated to be associated with several developmental and psychiatric illnesses. The polymorphisms of dopamine-related genes were examined for potential moderating influence on the effects of the intervention for child development.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.275 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: birth body weight < 1500 grams gestational age < 37 weeks parents of Taiwan nationality, married or together at delivery, and northern family residing in greater Taipei and southern family residing in greater Tainan, Kaohsiung, or Chiayi Exclusion Criteria: severe neonatal and perinatal diseases (e.g., seizures, hydrocephalus, meningitis, grade III-IV IVH and grade II NEC) congenital or chromosome abnormality mother < 18 years, with mental retardation or history of maternal substance abuse at any time (smoking, alcohol, and drug) Terminated Criteria: diagnosis of brain injury (e.g., PVL, stage IV ROP or greater) severe cardiopulmonary disease requiring invasive or non-invasive ventilator use at hospital discharge hospital discharge beyond 44 weeks' post-menstrual age.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
National Cheng Kung University Hospital
Tainan, TaiwanOpen National Cheng Kung University Hospital in Google MapsNational Taiwan University Hospital
Taipei, TaiwanMackay Memorial Hospital
Taipei, Taiwan