Developmental Intervention for Hospitalized Newborns With Congenital Heart Disease

NCT05885113 | Unknown

• 1 other identifier: IRB-P00044306
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Cardiology; Infant Development; Development Delay

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Neonatal Network Neurobehavioral Scale II (NNNS) of Young Children-Second Edition (DAYC-2)

  up to 2 months of age

• Developmental Assessment of Young Children-Second Edition (DAYC-2)

  at 3 months of age

Study Arms (2)

Intervention

EXPERIMENTAL

NIDCAP developmental care group receiving intervention

Behavioral: NIDCAP Developmental Care

standard of care

NO INTERVENTION

NO intervention, control group, receiving standard of care

Interventions

NIDCAP Developmental Care BEHAVIORAL

The intervention of Individualized Developmental Care (IDC) is designed to minimize the mismatch between the fragile infant brain's expectations and the experiences of stress and pain inherent in the hospital environment. An ICU that provides individualized, developmentally-supportive care includes a soothing environment, supports parents as their child's primary caregiver, providing continual adjustment of caregiving in support of the child's wellbeing by reading the infant's cues and providing interventions to calmness throughout caregiving, capitalizing on the infant's strengths, and providing supports toward healing, growth and learning. NIDCAP is the experimental intervention to be tested in the current study. NIDCAP is the only evidence-based, comprehensive, internationally recognized program of IDC.

Also known as: NIDCAP, Individualized Developmental Care

Intervention

Eligibility Criteria

• Age: Up to 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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
• 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.

You may not qualify if:

• Patients who experience cardiac arrest, CPR, ECMO, or VAD prior to recruitment

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Related Publications (6)

• 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.0000000000000264.

  PMID: 27140031 RESULT

• 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. doi: 10.1097/JCN.0000000000000546.

  PMID: 30303895 RESULT

• 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/chd.12686. Epub 2018 Oct 15.

  PMID: 30324749 RESULT

• 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.jpeds.2020.01.043. Epub 2020 Mar 5.

  PMID: 32147219 RESULT

• 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.

  PMID: 15060237 RESULT

• 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 in the Young, Council on Cardiovascular Nursing, and Stroke Council. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012 Aug 28;126(9):1143-72. doi: 10.1161/CIR.0b013e318265ee8a. Epub 2012 Jul 30.

  PMID: 22851541 RESULT

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Samantha Butler, PhD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

samantha butler, PhD

CONTACT

6173557483; samantha.butler@childrens.harvard.edu

Katrina Severtson, BS

CONTACT

6173553401; katrina.severtson@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will be a single center, single-blinded, two-arm before-and-after trial to test the feasibility of IDC vs. SOC in newborns with CHD after newborn open-heart surgery.

Study Record Dates

• First Submitted: May 9, 2023
• First Posted: June 1, 2023
• Study Start: October 10, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)