A Family-Centered Intervention Program for Preterm Infants: Effects and Their Biosocial Pathways

Plain-language summary

This study evaluates the effects of a family-centered intervention program in preterm (early-born) infants and its biosocial pathways, compared with usual care. It included infants born before 37 weeks weighing under 1500 grams, and their families. It is a non-phase study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Completed

Sponsor

National Taiwan University Hospital

Intervention

Family-centered intervention program, Usual care intervention program

Start date

5/22/2012

Estimated completion

1/10/2017

Countries

Taiwan

Related genes

Locations

• Tainan, Taiwan
• Taipei, Taiwan
• Taipei, Taiwan

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.