Ignite Creation Date:
2024-05-06 @ 7:04 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05885113
Status:
RECRUITING
Last Update Posted:
2023-11-15
First Post:
2023-05-09
Brief Title:
Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease
Sponsor:
Boston Childrens Hospital
Organization:
Boston Childrens Hospital
Study Overview
Official Title:
Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study includes a newborn developmental intervention to improve neurodevelopmental ND and medical outcomes for infants with congenital heart disease CHD with improved parent well-being Literature documents long-term ND disabilities for children with CHD caused by the negative effects of the hospital environment on the developing newborn brain The cardiac intensive care unit CICU while necessary to save the life of the infant with CHD exposes infants to overwhelming stress through painful procedures invasive lines and tubes toxic sensory stimulation and separation from family The combination of these negative experiences disrupts the infants brain maturation and subsequent neurodevelopment Individualized developmental care IDC is an intervention that minimizes the mismatch between infant neurobiological needs and the harsh hospital environment thereby diminishing the frequency and severity of adverse effects Core components of IDC include support for parent engagement caregiving provided in a way to reduce infant stress providing a soothing environment and appropriately positioning to enhance musculoskeletal and motor development Research shows that IDC improves outcomes for preterm infants with enhanced brain structure and function cognitive skills executive functioning behavioral outcomes and family satisfaction from infancy to school age Despite all the positive evidence for IDC my past research showed most CICUs do not implement IDC due to lack of staff education and no evidence supporting IDC in CHD
The investigators propose the first randomized controlled trial to evaluate the efficacy of IDR as an intervention for children with CHD The investigators hypothesize infants receiving IDC provided in the hospital compared to those not receiving IDC will show improved medical outcomes including shorter hospital stay improved oral feeding increased growth improved developmental competence and increased parent coping at the time of discharge home and 3 months after discharge With support from the Childrens Heart Foundation the investigators can demonstrate the feasibility and safety of implementing IDC in the CICU the potential to improve the ND outcome for infants with CHD and increase parent well-being This study would serve as the needed pilot study to request funding for a larger multicenter trial which would impact CICU care of infants with CHD and their families around the world
The investigators propose the first randomized controlled trial to evaluate the efficacy of IDR as an intervention for children with CHD The investigators hypothesize infants receiving IDC provided in the hospital compared to those not receiving IDC will show improved medical outcomes including shorter hospital stay improved oral feeding increased growth improved developmental competence and increased parent coping at the time of discharge home and 3 months after discharge With support from the Childrens Heart Foundation the investigators can demonstrate the feasibility and safety of implementing IDC in the CICU the potential to improve the ND outcome for infants with CHD and increase parent well-being This study would serve as the needed pilot study to request funding for a larger multicenter trial which would impact CICU care of infants with CHD and their families around the world
Detailed Description:
Neurodevelopmental ND disabilities are the most common and arguably the most distressing long-term morbidity in survivors of critical congenital heart disease CHD1 As mortality rates for infants with CHD have declined the need to optimize neurological and ND outcomes in survivors has assumed ever-greater importance A myriad of studies document that longer ICU and hospital length of stay LOS after newborn surgery are among the strongest independent risk factors for ND delay even after adjusting for known complications and patient factors Few rigorous studies however have thoroughly tested the efficacy of bedside interventions to improve neurodevelopmental outcomes by reducing the environmental toxicities for newborns in the Cardiac Intensive Care Unit CICU and other in-patient settings Individualized Developmental Care IDC is an intervention that maximizes the infant neurobiological needs and minimizes the harsh hospital environment thereby diminishing the frequency and severity of adverse effects and improves long-term developmental outcomes Core components of IDC include support and education for the family at the bedside on how to care for an ill infant acknowledging family as the primary caregiver incorporation of family into hands on care and positive touch medical caregiving that reduces infant stress and supports the infant throughout and providing a soothing environment to promote healing growth and learning The Newborn Individualized Developmental Care and Assessment Program NIDCAP2 3 is the only evidence-based comprehensive internationally recognized program of IDC IDC in the NIDCAP model has been shown to improve outcomes for premature infants with enhanced brain structure and function along with improved behavioral outcomes that endure beyond infancy and into school age In addition many NIDCAP studies report benefits for medical outcomes such as decreased length of ICU and of hospital stay earlier oral feeding and increased weight gain4-11 IDC as a developmental care intervention is novel in the CHD population ie it has not been routinely used or tested in newborns with CHD There is a critical need to translate this effective intervention of IDC into policy and routine care service for all infants and children hospitalized especially those with CHD This study supports the recent outreach to improve the implementation of effective interventions identified as a priority of health care systems and research agencies internationally12
The proposed study would thus be the first to test the feasibility of IDC as a hospital intervention for very high-risk newborns with CHD In this pilot single-center single blind before-and-after feasibility study the investigators will compare two types of experience standard newborn care SOC and the newborn intervention of developmental care IDC strictly following the NIDCAP model of care in the cardiology inpatient unit The investigators will focus on the process of implementing NIDCAP care in cardiology Following this feasibility study the researchers will then identify strategies to address the noted challenges andor revise components of the intervention prior to designing a multisite study to more formally evaluate the NIDCAP intervention in cardiology Specific aims are as follows
Primary Aim To describe feasibility for providing IDC for infants with CHD while inpatient in cardiology The investigators will describe organizationalcontextual factors which influence future implementation trial methods such as recruitment retention data collection procedures implementation of study protocol and any safety concerns
Hypothesis 1 IDC will be feasible to implement in the CICU and the cardiology step down unit Acute Cardiology Care Unit ACCU Infants who receive the IDC intervention will show an appropriate level score of 35 or higher of developmental care at the bedside during caregiving on the measure of developmental care NIDCAP Organizational Structures Assessment13 OSA scored by a study observer blind to study group The IDC group infants will have higher scores on the OSA measurement of developmental care at the bedside than the SOC group infants
Hypothesis 2 It will be possible to recruit enough patients into the study over the two year time frame The investigators will collect the number of patients eligible for the study number approached for the study the number consented and those that discontinue or drop from the study along with reasoning for why someone did not meet criteria or choose to leave the study
Hypothesis 3 There will be no safety concerns as reported by the Safety Event Reporting System SERS in connection with this NIDCAP study The investigators will review each month the number of SERS reported in the CICU and ACCU related to the study
Secondary Aims
1 To describe the feasibility of collecting the developmental outcome assessments in this cardiac population
Hypothesis 1 It will be feasible to collect the Neonatal Network Neurobehavioral Scale II NNNS and the Developmental Assessment of Young Children-Second Edition DAYC-2 on this population of infants The number of missing variables will be assessed
2 To demonstrate sufficient differentiation of developmental care and to estimate potential effect sizes to inform the design of an adequately powered trial using the OSA scores and parent diaries
3 To describe feasibility of increasing parent participation at the bedside large component of NIDCAP care for infants with CHD while inpatient in cardiology
Hypothesis 1 Infants in the intervention group IDC receiving NIDCAP care will have parents who are more engaged at the bedside with higher scores indicated increased engagement on the Parent Risk Evaluation and Engagement Model Instrument PREEMI than parents of infants receiving SOC
Hypothesis 2 Due to the increased attention to parent infant interaction given through the NIDCAP intervention parents in the IDC group will report more time at the bedside and more daily interaction with their child on the daily diary of care than parents in the SOC group
Our feasibility trial will provide the first urgently needed proof-of-concept that IDC can be implemented in hospitalized critically ill newborns with CHD When proven to be successful this study will provide information vital to funding of a multicenter randomized trial further expanding the knowledge of IDC for infants with CHD
The proposed study would thus be the first to test the feasibility of IDC as a hospital intervention for very high-risk newborns with CHD In this pilot single-center single blind before-and-after feasibility study the investigators will compare two types of experience standard newborn care SOC and the newborn intervention of developmental care IDC strictly following the NIDCAP model of care in the cardiology inpatient unit The investigators will focus on the process of implementing NIDCAP care in cardiology Following this feasibility study the researchers will then identify strategies to address the noted challenges andor revise components of the intervention prior to designing a multisite study to more formally evaluate the NIDCAP intervention in cardiology Specific aims are as follows
Primary Aim To describe feasibility for providing IDC for infants with CHD while inpatient in cardiology The investigators will describe organizationalcontextual factors which influence future implementation trial methods such as recruitment retention data collection procedures implementation of study protocol and any safety concerns
Hypothesis 1 IDC will be feasible to implement in the CICU and the cardiology step down unit Acute Cardiology Care Unit ACCU Infants who receive the IDC intervention will show an appropriate level score of 35 or higher of developmental care at the bedside during caregiving on the measure of developmental care NIDCAP Organizational Structures Assessment13 OSA scored by a study observer blind to study group The IDC group infants will have higher scores on the OSA measurement of developmental care at the bedside than the SOC group infants
Hypothesis 2 It will be possible to recruit enough patients into the study over the two year time frame The investigators will collect the number of patients eligible for the study number approached for the study the number consented and those that discontinue or drop from the study along with reasoning for why someone did not meet criteria or choose to leave the study
Hypothesis 3 There will be no safety concerns as reported by the Safety Event Reporting System SERS in connection with this NIDCAP study The investigators will review each month the number of SERS reported in the CICU and ACCU related to the study
Secondary Aims
1 To describe the feasibility of collecting the developmental outcome assessments in this cardiac population
Hypothesis 1 It will be feasible to collect the Neonatal Network Neurobehavioral Scale II NNNS and the Developmental Assessment of Young Children-Second Edition DAYC-2 on this population of infants The number of missing variables will be assessed
2 To demonstrate sufficient differentiation of developmental care and to estimate potential effect sizes to inform the design of an adequately powered trial using the OSA scores and parent diaries
3 To describe feasibility of increasing parent participation at the bedside large component of NIDCAP care for infants with CHD while inpatient in cardiology
Hypothesis 1 Infants in the intervention group IDC receiving NIDCAP care will have parents who are more engaged at the bedside with higher scores indicated increased engagement on the Parent Risk Evaluation and Engagement Model Instrument PREEMI than parents of infants receiving SOC
Hypothesis 2 Due to the increased attention to parent infant interaction given through the NIDCAP intervention parents in the IDC group will report more time at the bedside and more daily interaction with their child on the daily diary of care than parents in the SOC group
Our feasibility trial will provide the first urgently needed proof-of-concept that IDC can be implemented in hospitalized critically ill newborns with CHD When proven to be successful this study will provide information vital to funding of a multicenter randomized trial further expanding the knowledge of IDC for infants with CHD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None