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

Primary Purpose

Premature Birth

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
H-HOPE
Attention Control
Sponsored by
University of Illinois at Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring preterm infant, stable infant, mother-infant interaction, health care cost, H-HOPE intervention, mother outcomes, infant behavioral organization, infant growth

Eligibility Criteria

2 Hours - 45 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

-

Sites / Locations

  • Mercy Hospital and Medical Center
  • Mount Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Attention Control

H-HOPE Intervention

Arm Description

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

H-HOPE was administered twice daily by the mother.

Outcomes

Primary Outcome Measures

Infant Behavioral Organization
Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.
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.

Secondary Outcome Measures

Infant Growth
Infant growth in weight gain was measured at entry I into the study and at hospital discharge.
Health Care Utilization
Illness visits within 6 weeks post discharge

Full Information

First Posted
January 15, 2014
Last Updated
March 17, 2021
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)
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1. Study Identification

Unique Protocol Identification Number
NCT02041923
Brief Title
Feeding and Transition to Home for Preterms at Social Risk
Acronym
H-HOPE
Official Title
Feeding and Transition to Home for Preterms at Social Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
preterm infant, stable infant, mother-infant interaction, health care cost, H-HOPE intervention, mother outcomes, infant behavioral organization, infant growth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Attention Control
Arm Type
Placebo Comparator
Arm Description
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
Arm Title
H-HOPE Intervention
Arm Type
Experimental
Arm Description
H-HOPE was administered twice daily by the mother.
Intervention Type
Behavioral
Intervention Name(s)
H-HOPE
Other Intervention Name(s)
ATVV Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention Control
Other Intervention Name(s)
Education
Intervention Description
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
Primary Outcome Measure Information:
Title
Infant Behavioral Organization
Description
Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.
Time Frame
From birth to 36 weeks
Title
Mother-Infant Interaction
Description
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.
Time Frame
34 - 44 weeks postmenstrual age
Secondary Outcome Measure Information:
Title
Infant Growth
Description
Infant growth in weight gain was measured at entry I into the study and at hospital discharge.
Time Frame
from birth to hospital discharge, up to 9 weeks
Title
Health Care Utilization
Description
Illness visits within 6 weeks post discharge
Time Frame
Illness visits within 6 weeks post hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Hours
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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 -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rosemary C. White-Traut, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mercy Hospital and Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Mount Sinai Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31913324
Citation
Vonderheid SC, Park CG, Rankin K, Norr KF, White-Traut R. Impact of an integrated mother-preterm infant intervention on birth hospitalization charges. J Perinatol. 2020 Jun;40(6):858-866. doi: 10.1038/s41372-019-0567-7. Epub 2020 Jan 8.
Results Reference
derived
PubMed Identifier
28399825
Citation
Arianas EA, Rankin KM, Norr KF, White-Traut RC. Maternal weight status and responsiveness to preterm infant behavioral cues during feeding. BMC Pregnancy Childbirth. 2017 Apr 11;17(1):113. doi: 10.1186/s12884-017-1298-4.
Results Reference
derived
Links:
URL
https://www.ncbi.nlm.nih.gov/myncbi/1zuy2pmUXmu5a/bibliography/public/
Description
Mybiblio

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Feeding and Transition to Home for Preterms at Social Risk

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