Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Early Intervention for Preterm Infants
Brief Summary: The first aim is to develop a clinic-based intervention program and a home-based intervention program for VLBW preterm infants that have common intervention services but are respectively delivered at clinic and home. The interventions are comprehensive that combine child- and parent-focused services including health and feeding consultation, education of child development skills, intervention of mother-infant interaction, and parent support. The eleven-session interventions are intensive that begin in hospitalization and end at 12 months of corrected age. The clinical feasibility and usefulness of implementing these intervention programs within the context of randomized intervention study subject to the existing constraints of the hospital and home settings will be tested in a pilot study.

The second aim is to conduct a randomized control trial to examine the costs and effectiveness of the UCP, the CBIP, and the HBIP for VLBW preterm infants. Gender and socio-economically matched normal full-term infants will also be included as a comparison group. Outcome measures that include child, parenting, and transactions outcomes will be compared between groups. Child outcome measures will include health status, growth, neurodevelopment, and neurosensory status; parenting outcome measures will include maternal parenting competence, social support, and psychological stress; transactions outcome measure will be mother-infant interaction. Costs (direct and indirect costs) associated with each early intervention program during the follow-up period will be estimated. Average and incremental cost/effectiveness ratio will be calculated to determine which early intervention program is most cost-effective for VLBW preterm infants.


Options:
A: Arm Label: Term group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Usual care program group; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Clinic-based interveniton program group; Type: EXPERIMENTAL; Interventions: Behavioral: clinic-based intervention program and home-based intervention program | Arm Label: Home-based interveniton program group; Type: EXPERIMENTAL; Interventions: Behavioral: clinic-based intervention program and home-based intervention program | Intervention Type: BEHAVIORAL; Name: clinic-based intervention program and home-based intervention program; Assigned to Arm(s): Clinic-based interveniton program group, Home-based interveniton program group
B: Arm Label: Phase 1: Standard Care; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: Phase 1: Facilitated infant care; Type: EXPERIMENTAL; Interventions: Behavioral: Family Nurture Intervention | Arm Label: Phase 2: Effectiveness; Type: ACTIVE_COMPARATOR; Interventions: Behavioral: Family Nurture Intervention | Intervention Type: BEHAVIORAL; Name: Family Nurture Intervention; Assigned to Arm(s): Phase 1: Facilitated infant care, Phase 2: Effectiveness
C: Arm Label: Intervention; Type: EXPERIMENTAL; Interventions: Other: Physical Therapy Early Intervention | Arm Label: Control; Type: OTHER; Interventions: Other: Usual Care | Intervention Type: OTHER; Name: Physical Therapy Early Intervention; Assigned to Arm(s): Intervention | Intervention Type: OTHER; Name: Usual Care; Assigned to Arm(s): Control
D: Arm Label: CareToy Intervention; Type: EXPERIMENTAL; Interventions: Device: CareToy intervention | Arm Label: Infant Massage; Type: ACTIVE_COMPARATOR; Interventions: Other: Infant Massage | Intervention Type: DEVICE; Name: CareToy intervention; Assigned to Arm(s): CareToy Intervention | Intervention Type: OTHER; Name: Infant Massage; Assigned to Arm(s): Infant Massage

Answer: A