Trial record 16 of 16 for:    nichd High-Risk Pregnancy

Feeding and Transition to Home for Preterms at Social Risk (H-HOPE)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Rosemary White-Traut, University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT02041923
First received: January 15, 2014
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Premature Birth
Behavioral: H-HOPE

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Feeding and Transition to Home for Preterms at Social Risk

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • Infant Behavioral Organization [ Time Frame: From birth to 36 weeks ] [ Designated as safety issue: No ]
    The frequency of orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing), percent time in each infant behavioral state (alert, asleep, drowsy), and sucking organization (mean sucking pressure, number of sucks per burst, total number of suck, sucking maturity index) .

  • Maternal Outcomes [ Time Frame: After birth through the infant reaching six weeks corrected age ] [ Designated as safety issue: No ]
    maternal recognition of infant behavioral cues greater confidence in infant care more positive perception of the infant maternal lower anxiety

  • Mother-Infant Interaction [ Time Frame: 34 - 44 weeks postmenstrual age ] [ Designated as safety issue: No ]
    Mother-infant interaction during feeding (Nursing Child Assessment Feeding Scale) and play (Dyadic mutuality Code).


Secondary Outcome Measures:
  • Infant Growth [ Time Frame: from birth to 44 weeks postmenstrual age ] [ Designated as safety issue: No ]
    Infant growth in weight gain, length, and head circumference

  • Health care cost [ Time Frame: birth to 44 weeks postmenstrual age ] [ Designated as safety issue: No ]
    hospital cost, number of outpatient and specialty visits, number of hospitalizations

  • Infant development [ Time Frame: birth to 44 weeks postmentrual age ] [ Designated as safety issue: No ]
    Measured by the Bayley Scales of infant Development and the Test of infant Motor Performance


Enrollment: 230
Study Start Date: January 2007
Study Completion Date: June 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Attention Control
Mothers received equal amount of attention from the team
Experimental: H-HOPE Intervention
H-HOPE was administered twice daily by the mother.
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 Name: ATVV Intervention

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02041923

Locations
United States, Illinois
Mercy Hospital and Medical Center
Chicago, Illinois, United States, 60612
Mount Sinai Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
Investigators
Principal Investigator: Rosemary C. White-Traut, PhD University of Illinois at Chicago
  More Information

No publications provided

Responsible Party: Rosemary White-Traut, Professor (retired), University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT02041923     History of Changes
Other Study ID Numbers: 2005-0139, 1R01HD050738
Study First Received: January 15, 2014
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Illinois at Chicago:
preterm infant
stable infant
mother-infant interaction
health care cost
H-HOPE intervention
mother outcomes
infant behavioral organization
infant growth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 20, 2014