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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD050738 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| National Institute of Nursing Research (NINR) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Attention Control | Placebo Comparator | Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care. |
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| H-HOPE Intervention | Experimental | H-HOPE was administered twice daily by the mother. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| H-HOPE | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Infant Growth | 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 | Illness visits within 6 weeks post discharge |
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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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| Name | Affiliation | Role |
|---|---|---|
| Rosemary C. White-Traut, PhD | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mercy Hospital and Medical Center | Chicago | Illinois | 60612 | United States | ||
| Mount Sinai Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31913324 | Derived | 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. | |
| 28399825 | Derived | 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. |
| Label | URL |
|---|---|
| Mybiblio | View source |
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Random assignment was conducted after enrollment.
Infants and their mothers were screened by the research team. Mothers of eligible infants were approached for consent. We had IRB approval to recruit 230 mother-infants dyads. We recruited 198 total mother-infant dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | Attention Control | Mothers received equal amount of attention from the team 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. |
| FG001 | H-HOPE Intervention | H-HOPE was administered twice daily by the mother. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Attention Control | Mothers received equal amount of attention from the team 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Infant Behavioral Organization | Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week. | Posted | Mean | Standard Deviation | Orally directed behavioral cues per week | From birth to 36 weeks |
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No adverse events occurred during participant enrollment and participation - over a 4 month period..
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Attention Control | Mothers received equal amount of attention from the team 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rosemary White-Traut | University of Illinois at Chicago | 312-996-7935 | rwt@uic.edu |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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|
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| Attention Control | Other | Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care. |
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| Illness visits within 6 weeks post hospital discharge |
| Chicago |
| Illinois |
| 60612 |
| United States |
| BG001 | H-HOPE Intervention | H-HOPE was administered twice daily by the mother. 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. |
| BG002 | Total | Total of all reporting groups |
| weeks of gestation |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | units on a scale | 34 - 44 weeks postmenstrual age |
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|
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| Secondary | Infant Growth | Infant growth in weight gain was measured at entry I into the study and at hospital discharge. | Posted | Mean | Standard Deviation | weight in grams | from birth to hospital discharge, up to 9 weeks |
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| Secondary | Health Care Utilization | Illness visits within 6 weeks post discharge | Infant outpatient illness appointments | Posted | Mean | Standard Deviation | Illness visits | Illness visits within 6 weeks post hospital discharge |
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| 0 |
| 102 |
| 0 |
| 102 |
| 0 |
| 102 |
| EG001 | H-HOPE Intervention | H-HOPE was administered twice daily by the mother. 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. | 0 | 96 | 0 | 96 | 0 | 96 |
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| D000091642 | Urogenital Diseases |