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

March 17, 2021 updated by: Rosemary White-Traut, University of Illinois at Chicago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Mercy Hospital and Medical Center
      • Chicago, Illinois, United States, 60612
        • Mount Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 hours to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Attention Control
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
Other: Attention Control
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
Other Names:
  • Education
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 Names:
  • ATVV Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Behavioral Organization
Time Frame: From birth to 36 weeks
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
Mother-Infant Interaction
Time Frame: 34 - 44 weeks postmenstrual age
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant Growth
Time Frame: from birth to hospital discharge, up to 9 weeks
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
Health Care Utilization
Time Frame: Illness visits within 6 weeks post hospital discharge
Illness visits within 6 weeks post discharge
Illness visits within 6 weeks post hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Chicago

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Rosemary C. White-Traut, PhD, University of Illinois at Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

January 15, 2014

First Submitted That Met QC Criteria

January 17, 2014

First Posted (ESTIMATE)

January 22, 2014

Study Record Updates

Last Update Posted (ACTUAL)

April 13, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-0139
  • 1R01HD050738 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Birth

Clinical Trials on Attention Control

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Liberia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe