Premature BirthH-HOPENCT02041923
Feeding and Transition to Home for Preterms at Social Risk
A study testing H-HOPE in people with Premature Birth, run by University of Illinois Chicago at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 2 hours to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Premature Birth
- What is being tested?
- H-HOPE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Jun 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 hours to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 2 children less than 24 months old
- 4 or more children living in the home
- living in a disadvantaged neighborhood
Who cannot join
- 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
- -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mercy Hospital and Medical Center
Chicago, Illinois, 60612
Mount Sinai Medical Center
Chicago, Illinois, 60612
About this study
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- H-HOPE, Attention Control
- Keywords
- preterm infant, stable infant, mother-infant interaction, health care cost, H-HOPE intervention, mother outcomes, infant behavioral organization, infant growth
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H-HOPEBehavioural
Also called ATVV Intervention
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.
Attention ControlOther
Also called Education
Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
| Study group | Role | What they receive |
|---|---|---|
| Attention Control | Placebo comparator | Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care. Receives: Other: Attention Control |
| H-HOPE Intervention | Experimental | H-HOPE was administered twice daily by the mother. Receives: Behavioral: H-HOPE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infant Behavioral Organization
Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.
Measured: 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.
Measured: 34 - 44 weeks postmenstrual age
Secondary outcomes (2)
Infant Growth
Infant growth in weight gain was measured at entry I into the study and at hospital discharge.
Measured: from birth to hospital discharge, up to 9 weeks
Health Care Utilization
Illness visits within 6 weeks post discharge
Measured: Illness visits within 6 weeks post hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2014 (estimated)
- Study startJan 2007
- Primary completionOct 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Rosemary White-Traut, University of Illinois Chicago
- Investigators
- Rosemary C. White-Traut, PhD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041923
- Sponsor's protocol ID
- 2005-0139
- Other IDs
- 1R01HD050738
- Acronym
- H-HOPE
- Status last verified
- Mar 2021
- First submitted
- 15 Jan 2014
- Last updated
- 13 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31913324Arianas 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.
PubMed 28399825
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feeding and Transition to Home for Preterms at Social Risk
- ClinicalTrials.gov ID
- NCT02041923
- Acronym / sponsor ID
- H-HOPE / 2005-0139
- Conditions
- Premature Birth
- Keywords
- preterm infant, stable infant, mother-infant interaction, health care cost, H-HOPE intervention, mother outcomes, infant behavioral organization, infant growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Nursing Research (NINR)
- Study start
- Jan 2007
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Jan 2014 (estimated)
- Results
- Posted 13 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Control | Placebo comparator | Other: Attention ControlMothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care. |
| H-HOPE Intervention | Experimental | Behavioral: H-HOPEH-HOPE was administered twice daily by the mother. |
Who may qualify
- Ages
- 2 hours to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- Infant has congenital anomaly
- Necrotizing enterocolitis
- Brain injury
- chronic lung disease
- prenatal drug exposure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H-HOPEAlso: ATVV InterventionInfant 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. | Behavioural | H-HOPE Intervention |
| Attention ControlAlso: EducationMothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care. | Other | Attention Control |
Primary outcome
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.
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.
2 secondary outcomes
Infant Growth
Time frame: from birth to hospital discharge, up to 9 weeks
Health Care Utilization
Time frame: Illness visits within 6 weeks post hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31913324Vonderheid 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.
- Derived from this study: PubMed 28399825Arianas 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.
- MybiblioLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rosemary C. White-Traut, PhD principal investigator
University of Illinois Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing H-HOPE in people with Premature Birth, run by University of Illinois Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Behavioral Organization (time frame: From birth to 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02041923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021.