Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* gestational age ≥ 28+0 weeks and 32+6 weeks
* corrected age at baseline: between 3 and 9 months;
* achievement of predefined cut off scores in gross motor ability derived from Ages \& Stages Questionnaire® Third Edition (ASQ-3), in relation to corrected age (Bricker and Squires, 1999)

In detail:

* 4 months form (from 3 months to 4 months 30 days) score ≥ 10;
* 6 months form (from 5 months to 6 months 30 days) score ≥ 5 - \< 50;
* 8 months form (from 7 months to 8 months 30 days) ≥ 10 - \<30

Exclusion Criteria:

* infants with gestational age \< 28 weeks or ≥ 33 weeks
* infants small for gestational age (i.e. weight below the 10th, ref)
* presence of brain damage (i.e. brain malformation, intra-ventricular haemorrhage \[IVH\] \>1 ; any degree of periventricular leukomalacia (ref)
* known epilepsy or other form of seizure
* severe sensory deficits (blindness, deafness)
* other severe non neurological malformations
* participation in other experimental studies having rehabilitation aims
B: Inclusion Criteria for preterm infants:

* BW below 1,501 gm
* GA under 37 weeks
* Admission to the NICU within the first 7 days of life
* Physiologically stable at PCA 36 weeks as diagnosed by attending physician
* Hospital discharge prior to PCA 40 weeks
* Absence of congenital anomalies and/or severe neonatal diseases
* Family residence in the greater Taipei area.

Exclusion Criteria for preterm infants:

* Severe neonatal diseases included major neurologic abnormalities (such as seizures, hydrocephalus, ventriculoperitoneal shunt, meningitis, periventricular leukomalacia, grade III-IV intraventricular hemorrhage, and grade IV retinopathy of prematurity)
* Necrotizing enterocolitis with colostomy
* Severe cardiopulmonary disease requiring daily oxygen use at hospital discharge

Inclusion Criteria for full-term infants:

* Birth weight \>2,500 g;
* Gestational age within 38-42 weeks,
* Family living in the same geographic region as those of the VLBW preterm infants

Exclusion Criteria for full-term infants:

* Serious prenatal or perinatal complications
C: Inclusion Criteria:

* Birth weight \< 2000 gram

Exclusion Criteria:

* Congenital anomalies
* Non-Norwegian speaking mother
* Triplets
D: Inclusion Criteria:

* Child born before or at 32nd gestational week.
* Child that tolerates being handled at 34th week postmenstrual age.
* Parents that can perform the intervention understand and speak Norwegian.
* Follow up of the child in the hospital where the intervention is given.

Exclusion Criteria:

* Child born later than 32nd week.
* Child who cannot tolerate being handled for up to 10 minutes at 34th postmenstrual age.
* Triplets or more.
* Child who has undergone surgery.
* Child with large deformities.
* Parents that can perform the intervention but do not understand and speak Norwegian.
* Follow up of the child is not taking place in the hospital where the intervention is given.
* All children who fill the inclusion criteria will be included to begin with.
* If at a later stage they are unable to manage the tests due to their condition they will be excluded.

Answer: B