Feeding and Transition to Home for Preterms at Social Risk
H-HOPE
2 other identifiers
interventional
198
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 15, 2014
CompletedFirst Posted
Study publicly available on registry
January 22, 2014
CompletedResults Posted
Study results publicly available
April 13, 2021
CompletedApril 13, 2021
March 1, 2021
5.8 years
January 15, 2014
June 2, 2017
March 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
Infant Growth
from birth to hospital discharge, up to 9 weeks
Health Care Utilization
Illness visits within 6 weeks post hospital discharge
Study Arms (2)
Attention Control
PLACEBO COMPARATORMothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
H-HOPE Intervention
EXPERIMENTALH-HOPE was administered twice daily by the mother.
Interventions
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.
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
Eligibility Criteria
You may qualify if:
- 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
- children less than 24 months old
- or more children living in the home
- living in a disadvantaged neighborhood
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Mercy Hospital and Medical Center
Chicago, Illinois, 60612, United States
Mount Sinai Medical Center
Chicago, Illinois, 60612, United States
Related Publications (2)
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.
PMID: 31913324DERIVEDArianas 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.
PMID: 28399825DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Rosemary White-Traut
- Organization
- University of Illinois at Chicago
Study Officials
- PRINCIPAL INVESTIGATOR
Rosemary C. White-Traut, PhD
University of Illinois at Chicago
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor (retired)
Study Record Dates
First Submitted
January 15, 2014
First Posted
January 22, 2014
Study Start
January 1, 2007
Primary Completion
October 1, 2012
Study Completion
June 1, 2013
Last Updated
April 13, 2021
Results First Posted
April 13, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share