Trial Outcomes & Findings for Feeding and Transition to Home for Preterms at Social Risk (NCT NCT02041923)

NCT ID: NCT02041923

Last Updated: 2021-04-13

Results Overview

Orally directed behavioral cues (hand to mouth, hand swipes at mouth, sucking on hand, sucking on tongue, tonguing) per week.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 198 participants
• Primary outcome timeframe: From birth to 36 weeks
• Results posted on: 2021-04-13

Participant Flow

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.

Random assignment was conducted after enrollment.

Participant milestones

Measure	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.	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.
Overall Study STARTED	102	96
Overall Study COMPLETED	76	66
Overall Study NOT COMPLETED	26	30

Reasons for withdrawal

Measure	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.	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.
Overall Study Lost to Follow-up	26	30

Baseline Characteristics

Feeding and Transition to Home for Preterms at Social Risk

Baseline characteristics by cohort

Measure	Attention Control n=102 Participants 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.	H-HOPE Intervention n=96 Participants 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.	Total n=198 Participants Total of all reporting groups
Age, Continuous	32 weeks of gestation STANDARD_DEVIATION 1.6 • n=5 Participants	32 weeks of gestation STANDARD_DEVIATION 1.7 • n=7 Participants	32 weeks of gestation STANDARD_DEVIATION 1.7 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants	42 Participants n=7 Participants	85 Participants n=5 Participants
Sex: Female, Male Male	59 Participants n=5 Participants	54 Participants n=7 Participants	113 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · Black or African American	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Race (NIH/OMB) Race · White	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) Race · More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Race · Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Black	55 Participants n=5 Participants	53 Participants n=7 Participants	108 Participants n=5 Participants
Race/Ethnicity, Customized latino	47 Participants n=5 Participants	43 Participants n=7 Participants	90 Participants n=5 Participants
Region of Enrollment United States	102 participants n=5 Participants	96 participants n=7 Participants	198 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=102 Participants Mothers received equal amount of attention from the team.	H-HOPE Intervention n=96 Participants 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.
Infant Behavioral Organization	33.2 Orally directed behavioral cues per week Standard Deviation 42.4	51.8 Orally directed behavioral cues per week Standard Deviation 56.7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=76 Participants Mothers received equal amount of attention from the team.	H-HOPE Intervention n=66 Participants 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.
Mother-Infant Interaction	62.5 units on a scale Standard Deviation 7.0	64.3 units on a scale Standard Deviation 5.2

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Attention Control n=37 Participants Mothers received equal amount of attention from the team.	H-HOPE Intervention n=36 Participants 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.
Infant Growth	2038 weight in grams Standard Deviation 228	2051 weight in grams Standard Deviation 284

SECONDARY outcome

Timeframe: Illness visits within 6 weeks post hospital discharge

Population: Infant outpatient illness appointments

Illness visits within 6 weeks post discharge

Outcome measures

Measure	Attention Control n=69 Participants Mothers received equal amount of attention from the team.	H-HOPE Intervention n=78 Participants 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.
Health Care Utilization	15 Illness visits Standard Deviation 2.8	10 Illness visits Standard Deviation 1.2

Adverse Events

Attention Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

H-HOPE Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rosemary White-Traut

University of Illinois at Chicago

Phone: 312-996-7935

Email: rwt@uic.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place