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Feeding and Transition to Home for Preterms at Social Risk

Feeding and Transition to Home for Preterms at Social Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02041923
Acronym
H-HOPE
Enrollment
198
Registered
2014-01-22
Start date
2007-01-31
Completion date
2013-06-30
Last updated
2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Birth

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

BEHAVIORALH-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.

OTHERAttention Control

Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
National Institute of Nursing Research (NINR)
CollaboratorNIH
University of Illinois at Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Hours to 45 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Infant Behavioral OrganizationFrom birth to 36 weeksOrally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.
Mother-Infant Interaction34 - 44 weeks postmenstrual ageMother-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

MeasureTime frameDescription
Infant Growthfrom birth to hospital discharge, up to 9 weeksInfant growth in weight gain was measured at entry I into the study and at hospital discharge.
Health Care UtilizationIllness visits within 6 weeks post hospital dischargeIllness 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

ArmCount
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
Total198

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up2630

Baseline characteristics

CharacteristicH-HOPE InterventionTotalAttention Control
Age, Continuous32 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 Participants90 Participants47 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
53 Participants108 Participants55 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race/Ethnicity, Customized
Black
53 Participants108 Participants55 Participants
Race/Ethnicity, Customized
latino
43 Participants90 Participants47 Participants
Race (NIH/OMB)
Race
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
Black or African American
53 Participants108 Participants55 Participants
Race (NIH/OMB)
Race
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Race
White
43 Participants90 Participants47 Participants
Region of Enrollment
United States
96 participants198 participants102 participants
Sex: Female, Male
Female
42 Participants85 Participants43 Participants
Sex: Female, Male
Male
54 Participants113 Participants59 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1020 / 96
other
Total, other adverse events
0 / 1020 / 96
serious
Total, serious adverse events
0 / 1020 / 96

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
Attention ControlInfant Behavioral Organization33.2 Orally directed behavioral cues per weekStandard Deviation 42.4
H-HOPE InterventionInfant Behavioral Organization51.8 Orally directed behavioral cues per weekStandard Deviation 56.7
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.

Time frame: 34 - 44 weeks postmenstrual age

ArmMeasureValue (MEAN)Dispersion
Attention ControlMother-Infant Interaction62.5 units on a scaleStandard Deviation 7
H-HOPE InterventionMother-Infant Interaction64.3 units on a scaleStandard Deviation 5.2
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Attention ControlHealth Care Utilization15 Illness visitsStandard Deviation 2.8
H-HOPE InterventionHealth Care Utilization10 Illness visitsStandard Deviation 1.2
Secondary

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

ArmMeasureValue (MEAN)Dispersion
Attention ControlInfant Growth2038 weight in gramsStandard Deviation 228
H-HOPE InterventionInfant Growth2051 weight in gramsStandard Deviation 284
p-value: <0.05t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026