Feeding and Transition to Home for Preterms at Social Risk

Premature Birth Clinical Trial

— H-HOPE  

Official title:

Feeding and Transition to Home for Preterms at Social Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02041923
• Other study ID #: 2005-0139
• Secondary ID: 1R01HD050738
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: June 2013

Study information

• Verified date: March 2021
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 is innovative because it integrates two components used successfully in prior research but never before combined. Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants. The synergistic effect of these simultaneous improvements for infant and mother should lead to: 1) more mature infant behavioral organization and hospital progression; 2) improved maternal recognition of infant behavioral cues, greater confidence in infant care, more positive perception of the infant, and lower anxiety; 3) more positive mother-infant interaction and greater mother-infant contingency; 4) improved infant development and growth; and 5) lower infant health care utilization and costs. H-HOPE provides intervention from 32 weeks GA to one month corrected age, a time of transition to oral feeding, from the hospital to home, and from hospital to outpatient providers, when mothers of premature infants express need for support. We will randomly assign 252 infants to the H-HOPE or the Attention Control group. Power analysis shows that with an 80% retention rate, we will have adequate power to identify expected intervention effects. Variables are measured during hospital stay, at intake, immediately prior to discharge, and at six weeks corrected age. Analyses employ Hierarchical Linear Modeling clustered within clinical sites, with infant sex, biologic and social-environmental risk factors as covariates. If successful, H-HOPE will provide a national model for improving early infant health and development and reducing health costs. For example, reducing hospital stays by just three days for the almost 500,000 infants born prematurely could save over two billion dollars annually.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 45 Years

Eligibility

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

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Related Conditions & MeSH terms

• Premature Birth

Intervention

Behavioral:
• H-HOPE
Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.

Other:
• Attention Control
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.

Locations

Country	Name	City	State
United States	Mercy Hospital and Medical Center	Chicago	Illinois
United States	Mount Sinai Medical Center	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Chicago	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Behavioral Organization	Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.	From birth to 36 weeks
Primary	Mother-Infant Interaction	Mother-infant interaction during feeding measured via the Nursing Child Assessment Feeding Scale (NCAFS). The NCAFS possible scores ranged from 0-76. A higher score indicates a better outcome.	34 - 44 weeks postmenstrual age
Secondary	Infant Growth	Infant growth in weight gain was measured at entry I into the study and at hospital discharge.	from birth to hospital discharge, up to 9 weeks
Secondary	Health Care Utilization	Illness visits within 6 weeks post discharge	Illness visits within 6 weeks post hospital discharge

External Links

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