Premature Birth
Conditions
Keywords
preterm infant, stable infant, mother-infant interaction, health care cost, H-HOPE intervention, mother outcomes, infant behavioral organization, infant growth
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.
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.
Sponsors
Study design
Eligibility
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 \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant Behavioral Organization | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant Growth | 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. |
| Health Care Utilization | Illness visits within 6 weeks post hospital discharge | Illness visits within 6 weeks post discharge |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
Random assignment was conducted after enrollment.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| 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. | 96 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 26 | 30 |
Baseline characteristics
| Characteristic | H-HOPE Intervention | Total | Attention Control |
|---|---|---|---|
| Age, Continuous | 32 weeks of gestation STANDARD_DEVIATION 1.7 | 32 weeks of gestation STANDARD_DEVIATION 1.7 | 32 weeks of gestation STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 43 Participants | 90 Participants | 47 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 53 Participants | 108 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 53 Participants | 108 Participants | 55 Participants |
| Race/Ethnicity, Customized latino | 43 Participants | 90 Participants | 47 Participants |
| Race (NIH/OMB) Race American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Black or African American | 53 Participants | 108 Participants | 55 Participants |
| Race (NIH/OMB) Race More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Race White | 43 Participants | 90 Participants | 47 Participants |
| Region of Enrollment United States | 96 participants | 198 participants | 102 participants |
| Sex: Female, Male Female | 42 Participants | 85 Participants | 43 Participants |
| Sex: Female, Male Male | 54 Participants | 113 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 102 | 0 / 96 |
| other Total, other adverse events | 0 / 102 | 0 / 96 |
| serious Total, serious adverse events | 0 / 102 | 0 / 96 |
Outcome results
Infant Behavioral Organization
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Infant Behavioral Organization | 33.2 Orally directed behavioral cues per week | Standard Deviation 42.4 |
| H-HOPE Intervention | Infant Behavioral Organization | 51.8 Orally directed behavioral cues per week | Standard Deviation 56.7 |
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.
Time frame: 34 - 44 weeks postmenstrual age
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Mother-Infant Interaction | 62.5 units on a scale | Standard Deviation 7 |
| H-HOPE Intervention | Mother-Infant Interaction | 64.3 units on a scale | Standard Deviation 5.2 |
Health Care Utilization
Illness visits within 6 weeks post discharge
Time frame: Illness visits within 6 weeks post hospital discharge
Population: Infant outpatient illness appointments
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Health Care Utilization | 15 Illness visits | Standard Deviation 2.8 |
| H-HOPE Intervention | Health Care Utilization | 10 Illness visits | Standard Deviation 1.2 |
Infant Growth
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Attention Control | Infant Growth | 2038 weight in grams | Standard Deviation 228 |
| H-HOPE Intervention | Infant Growth | 2051 weight in grams | Standard Deviation 284 |