Feeding and Transition to Home for Preterms at Social Risk

Study Overview
=================
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.

Official Title
-----------------
Feeding and Transition to Home for Preterms at Social Risk

Conditions
-----------------
Premature Birth

Intervention / Treatment
-----------------
* Behavioral: H-HOPE
* Other: Attention Control


Participation Criteria
=================
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 -

Ages Eligible for Study
-----------------
Minimum Age: 2 Hours
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Attention Control<br>Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care. | Other: Attention Control<br>* Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.<br>* Other names: Education;|
| Experimental: H-HOPE Intervention<br>H-HOPE was administered twice daily by the mother. | Behavioral: H-HOPE<br>* 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.<br>* Other names: ATVV Intervention;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Illness visits within 6 weeks post hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant behavioral organization, preterm infant, stable infant, mother-infant interaction, health care cost, H-HOPE intervention, mother outcomes, infant growth