Infant Development Clinical Trial
Official title:
Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease
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 infant's 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 Children's 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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | May 1, 2025 |
Est. primary completion date | May 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 4 Months |
Eligibility | Inclusion Criteria: - admitted to the Cardiac Intensive Care Unit (CICU) at Boston Children's Hospital (BCH) within 3 days of birth - diagnoses of complex CHD with need for open heart surgery within the first two weeks of life (for example: total anomalous pulmonary venous connection, transposition of the great arteries, truncus arteriosus, VSD with interrupted aortic arch) - free from associated extracardiac anomalies that are moderate or severe - free from previous cardiac surgery or associated cardiovascular anomalies - GA greater than 37 weeks - 1 and 5 minute Apgar = 4 - free of known chromosomal and congenital abnormalities (e.g., Down syndrome, 22q11 deletion, Noonan syndrome, Williams syndrome) - free from multiple congenital anomalies (e.g., CHARGE syndrome) - mother's age = 20 = 45 years - absence of reported maternal alcohol, nicotine, or illegal drug use by maternal report and medical record review - telephone/internet access. Exclusion Criteria: - Patients who experience cardiac arrest, CPR, ECMO, or VAD prior to recruitment |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
Als H, Duffy FH, McAnulty GB, Rivkin MJ, Vajapeyam S, Mulkern RV, Warfield SK, Huppi PS, Butler SC, Conneman N, Fischer C, Eichenwald EC. Early experience alters brain function and structure. Pediatrics. 2004 Apr;113(4):846-57. doi: 10.1542/peds.113.4.846 — View Citation
Butler SC, Sadhwani A, Stopp C, Singer J, Wypij D, Dunbar-Masterson C, Ware J, Newburger JW. Neurodevelopmental assessment of infants with congenital heart disease in the early postoperative period. Congenit Heart Dis. 2019 Mar;14(2):236-245. doi: 10.1111 — View Citation
Lisanti AJ, Vittner D, Medoff-Cooper B, Fogel J, Wernovsky G, Butler S. Individualized Family-Centered Developmental Care: An Essential Model to Address the Unique Needs of Infants With Congenital Heart Disease. J Cardiovasc Nurs. 2019 Jan/Feb;34(1):85-93 — View Citation
Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, Mussatto KA, Uzark K, Goldberg CS, Johnson WH Jr, Li J, Smith SE, Bellinger DC, Mahle WT; American Heart Association Congenital Heart Defects Committee, Council on Cardiovascular Disease — View Citation
Miller TA, Lisanti AJ, Witte MK, Elhoff JJ, Mahle WT, Uzark KC, Alexander N, Butler SC. A Collaborative Learning Assessment of Developmental Care Practices for Infants in the Cardiac Intensive Care Unit. J Pediatr. 2020 May;220:93-100. doi: 10.1016/j.jped — View Citation
Sood E, Berends WM, Butcher JL, Lisanti AJ, Medoff-Cooper B, Singer J, Willen E, Butler S. Developmental Care in North American Pediatric Cardiac Intensive Care Units: Survey of Current Practices. Adv Neonatal Care. 2016 Jun;16(3):211-9. doi: 10.1097/ANC. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | NIDCAP Organizational Structures Assessment (OSA)) | Measure of Developmental Care in the hospital at the bedside; 0-5 with 5 being the best score. | up to 2 months of age | |
Secondary | Neonatal Network Neurobehavioral Scale II (NNNS) of Young Children-Second Edition (DAYC-2) | infant assessment; summary scores in percentile; 10-90 percentiles are considered normative performance. | up to 2 months of age | |
Secondary | Developmental Assessment of Young Children-Second Edition (DAYC-2) | infant assessment; standard score with 100 average and S.D. of 15. | at 3 months of age |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05793112 -
INF108F in Infants With Food Protein Induced Proctocolitis
|
Phase 4 | |
Recruiting |
NCT03828708 -
Early Iron Exposure on the Gut Microbiota in Young Infants
|
N/A | |
Recruiting |
NCT06018064 -
Investigating Fit and Satisfaction of the Prone Positioner
|
N/A | |
Not yet recruiting |
NCT06335524 -
Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants
|
N/A | |
Not yet recruiting |
NCT05039918 -
Neonatal Experience of Social Touch
|
N/A | |
Completed |
NCT01166867 -
A Pilot Study Using Photo-plethysmographic (PPG) Camera
|
||
Completed |
NCT00791466 -
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development
|
N/A | |
Completed |
NCT03331276 -
Growth and Safety Study of an Infant Formula for Healthy Term Infants
|
N/A | |
Completed |
NCT05157633 -
Oral Exploration of Objects and Food Diversification
|
||
Completed |
NCT05217186 -
Associations Between Early Neonatal Neuroimaging, Hammersmith Infant Neurological Examination and General Movements
|
||
Recruiting |
NCT05006989 -
Blueberry Intake and Infant Gut Health
|
N/A | |
Completed |
NCT04901611 -
Parental Touch Trial (Petal)
|
N/A | |
Completed |
NCT03082313 -
Movement-based Infant Intervention
|
N/A | |
Recruiting |
NCT06053515 -
Rosie the Chatbot: Leveraging Automated and Personalized Health Information Communication
|
N/A | |
Completed |
NCT05394883 -
The SPROUT (Pilot) Project
|
N/A | |
Completed |
NCT03991949 -
Evaluation of Preterm Infants Fed Post-Discharge Preterm Infant Formula
|
N/A | |
Active, not recruiting |
NCT03851120 -
Brain Probiotic and LC-PUFA Intervention for Optimum Early Life
|
Phase 2 | |
Completed |
NCT03662048 -
Improving Infant Sleep Safety With the Electronic Health Record
|
N/A | |
Active, not recruiting |
NCT04749888 -
Impact of the Korea Early Childhood Home-visiting Intervention
|
N/A | |
Recruiting |
NCT06230848 -
Multisensory Early Oral Administration of Human Milk in Preterm Infants
|
N/A |