N/A N=198 Randomized Single-blind Treatment

Feeding and Transition to Home for Preterms at Social Risk

Premature Birth

Bottom Line

View on ClinicalTrials.gov: NCT02041923 ↗

Enrolled (actual)

198

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Infant Behavioral Organization — 33.2; 51.8 Orally directed behavioral cues per week

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: H-HOPE (Behavioral); Attention Control (Other)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: University of Illinois at Chicago
Primary completion: Oct 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Infant Behavioral Organization	33.2; 51.8	—
PRIMARY Mother-Infant Interaction	62.5; 64.3	—
SECONDARY Infant Growth	2038; 2051	<0.05 sig
SECONDARY Health Care Utilization	15; 10	—

Summary

Premature infants are at high risk of suboptimal health and development. This randomized clinical trial evaluated the impact of a developmentally based intervention, H-HOPE (Hospital-home transition: optimizing prematures' environment), for infants born between 29-34 weeks gestational age (GA) with at least two social-environmental risk factors. H-HOPE will improve infant behavior, mother care for the infants, mother-infant interaction and will reduce health care costs.

Eligibility Criteria

Inclusion Criteria

29-34 weeks gestation at birth

no other major health problems

mothers have at least 2 socio-environmental risk factors such as African American or Latina

Less then high school education

history of mental illness

less than 150% poverty level

2 children less than 24 months old

4 or more children living in the home

living in a disadvantaged neighborhood

Exclusion Criteria

Infant has congenital anomaly

Necrotizing enterocolitis

Brain injury

chronic lung disease

prenatal drug exposure

mother is an illicit drug user

mother is not the legal guardian

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02041923). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.