Heart Defects, CongenitalNCT02781545
Motor Development of Children That Have Surgery as Newborns for Complex Congenital Heart Disease
An observational study of Heart Defects, Congenital, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial… Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Heart Defects, Congenital
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Consecutive infant sampling of infants with complex congenital heart diseases
Who may be able to join
- Infants diagnosed with complex congenital heart diseases that require surgery during the neonatal period, ages 0-30 days
- Surgical care at Advocate Christ Medical Center/Advocate Children's Hospital, Oak Lawn, Il
Who cannot join
- Chromosomal abnormalities and/or known syndromes
Trial locations and contacts
1 site in 1 country.
United States1 site
Advocate Children's Hospital
Oak Lawn, Illinois, 60453
About this study
Official title: Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates for Complex Congenital Heart Disease
Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%. Infants are often unable to withstand standardized developmental testing during early infancy due to medical fragility and sternal precautions after surgery. Evaluation of the quality of spontaneous movements and movement variability is a good alternative. The quality of general movements in early infancy is a valid predictor of neurological disorders in high risk infant groups and is assessed with short periods of video-recorded observations. This methodology has yet to be studied in infants with complex congenital heart disease that require surgery as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to document developmental outcome.
Read the detailed description
Congenital heart defects (CHD) are conditions present at birth and affect heart structure, function, and manner in which blood flows through the heart and to the rest of the body. The incidence of severe CHD is about 2.5 to 3/1,000 live births. With improvements in cardiac surgical technique and critical care medicine, the vast majority of babies with CHD are expected to survive to school age and beyond. However, these surgical and medical advances are also associated with increased risk for neurodevelopmental morbidity.
Traditionally, a quantitative approach measured gross motor development of infants at risk for delay, including children with complex congenital heart disease. These tools emphasize elicited responses; however, clinical use and validity may be limited by the infant's behavioral state, unstable physiological status, intolerance of handling, or sternal/surgical precautions. Alternatively, European clinicians working in the field of developmental neurology realized that variation and adaptability in motor behavior may assist in the evaluation of motor development. The application of motor variation and adaptability as a means to evaluate neuromotor condition in early infancy was significant for early detection of infants at high risk for developmental problems or cerebral palsy in a number of studies with high-risk infant groups. This form of evaluation has yet to be studied in infants with complex congenital heart diseases.
The proposed study aims to study motor development of two infant groups based on oxygen saturation targets after neonatal surgery and to study the validity of the assessment tools based on the quality of movement variation and adaptability, i.e., the General Movements Assessment (GMsA) and the Infant Motor Profile (IMP) in infants with complex congenital heart disease.
Hypothesis:
Baseline oxygen saturation after neonatal heart surgery in children with complex congenital heart diseases is a determinant of motor performance outcome at 18 months on the Infant Motor Profile.
Specific Objectives:
- To determine developmental outcomes at 18 months in two infant groups based on oxygen saturation targets.
- To validate specific neuromotor assessment tools that determine developmental outcome in two infant groups based on oxygen saturation targets.
Specific Aims:
- To compare motor outcomes at 18 months measured with the IMP of two groups of infants who had surgery as neonates for complex congenital heart disease grouped by baseline oxygen saturation targets after the first surgery (≥ 90%; high saturation and < 90%; low saturation, i.e., admixed lesions).
- To describe the quality of general movements from birth through three months at five assessment points in infants with high oxygen saturation and infants with low oxygen saturation.
- To describe motor development in terms of IMP-scores at 6, 12 and 18 months in infants with high oxygen saturation and infants with low oxygen saturation.
- To explore the predictive value of GMsA at three months in a pooled group of infants with high oxygen saturation and low oxygen saturation with development outcome at 18 months assessed with:
- Infant Motor Profile (IMP)
- Alberta Infant Motor Scales (AIMS)
- Motor Composite score of the Bayley Scales of Infant Development, 3rd edition (BSID-3)
- Cognitive and Language composite scores of the BSID-3.
- To determine the concurrent validity of the Infant Motor Profile (IMP) on the basis of comparison with:
- Alberta Infant Motor Scales (AIMS) at 6, 12, and 18 months.
- Bayley Motor Composite score at 18 months.
- Conditions
- Heart Defects, Congenital
- Keywords
- Child Development, Psychomotor Performance, Newborns, Surgery
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor development at 18 months
Comparison of motor development of two groups of infants based on oxygen saturation targets after neonatal surgery using the Infant Motor Profile
Measured: 18 months
Secondary outcomes (3)
Movement quality from birth to 4 months of age
Comparison of the trajectory of movement quality for two infant groups based on video recorded General Movements Assessments for at least three assessment points from birth to 4 months of age
Measured: 4 months. The infant's general movements are video-recorded three to five times from birth to four month according to this schedule: pre-operation (if possible), hospital discharge, one month of age, two months of age, and three months of age
Concurrent validity
Assess concurrent validity of the Infant Motor Profile total score and performance score with the Alberta Infant Motor Scales at 6, 12, and 18 months, and the Bayley Scales of Infant Development (3rd edition) motor composite score at 18 months
Measured: 18 months
Cognitive and language development at 18 months
Comparison of the two infant groups based on the cognitive and language composite scores of the Bayley Scales of Infant Development (3rd edition)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startMay 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Heart Defects, CongenitalStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Advocate Center for Pediatric Research, University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Darlene Huisenga, PT, DPT, PCS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781545
- Sponsor's protocol ID
- AHC IRB#6036
- Status last verified
- Oct 2024
- First submitted
- 18 May 2016
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Manuscript, Poster presentation, Conference presentation
Publications
Donofrio MT, Duplessis AJ, Limperopoulos C. Impact of congenital heart disease on fetal brain development and injury. Curr Opin Pediatr. 2011 Oct;23(5):502-11. doi: 10.1097/MOP.0b013e32834aa583.
PubMed 21881507Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
PubMed 12084585Brosig CL, Mussatto KA, Kuhn EM, Tweddell JS. Neurodevelopmental outcome in preschool survivors of complex congenital heart disease: implications for clinical practice. J Pediatr Health Care. 2007 Jan-Feb;21(1):3-12. doi: 10.1016/j.pedhc.2006.03.008.
PubMed 17198894Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
PubMed 11060529Hadders-Algra M. Variation and variability: key words in human motor development. Phys Ther. 2010 Dec;90(12):1823-37. doi: 10.2522/ptj.20100006. Epub 2010 Oct 21.
PubMed 20966209Hadders-Algra M. General movements: A window for early identification of children at high risk for developmental disorders. J Pediatr. 2004 Aug;145(2 Suppl):S12-8. doi: 10.1016/j.jpeds.2004.05.017.
PubMed 15292882Hamer EG, Bos AF, Hadders-Algra M. Assessment of specific characteristics of abnormal general movements: does it enhance the prediction of cerebral palsy? Dev Med Child Neurol. 2011 Aug;53(8):751-6. doi: 10.1111/j.1469-8749.2011.04007.x. Epub 2011 Jun 29.
PubMed 21711457Huisenga DC, la Bastide-van Gemert S, Van Bergen AH, Sweeney JK, Hadders-Algra M. Predictive value of General Movements Assessment for developmental delay at 18 months in children with complex congenital heart disease. Early Hum Dev. 2024 Jan;188:105916. doi: 10.1016/j.earlhumdev.2023.105916. Epub 2023 Dec 8.
PubMed 38091843
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting and Monitoring Motor Development of Children Requiring Surgery as Neonates for Complex Congenital Heart Disease
- ClinicalTrials.gov ID
- NCT02781545
- Acronym / sponsor ID
- AHC IRB#6036
- Conditions
- Heart Defects, Congenital
- Keywords
- Child Development, Psychomotor Performance, Newborns, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Advocate Center for Pediatric Research, University Medical Center Groningen
- Study start
- May 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 24 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infants requiring surgery in the neonatal period for complex congenital heart diseases are at risk for developmental problems. For infants with congenital heart diseases with admixture physiology and single ventricles, optimal circulation is associated with signs of adequate systemic perfusion and a systemic arterial oxygen saturation typically between 75% to 90%. Infants are often unable to withstand standardized developmental testing during early infancy due to medical fragility and sternal precautions after surgery. Evaluation of the quality of spontaneous movements and movement variability is a good alternative. The quality of general movements in early infancy is a valid predictor of neurological disorders in high risk infant groups and is assessed with short periods of video-recorded observations. This methodology has yet to be studied in infants with complex congenital heart disease that require surgery as neonates. For older infants, the Infant Motor Profile (IMP) is a promising tool to document developmental outcome.
Detailed description
Congenital heart defects (CHD) are conditions present at birth and affect heart structure, function, and manner in which blood flows through the heart and to the rest of the body. The incidence of severe CHD is about 2.5 to 3/1,000 live births. With improvements in cardiac surgical technique and critical care medicine, the vast majority of babies with CHD are expected to survive to school age and beyond. However, these surgical and medical advances are also associated with increased risk for neurodevelopmental morbidity.
Traditionally, a quantitative approach measured gross motor development of infants at risk for delay, including children with complex congenital heart disease. These tools emphasize elicited responses; however, clinical use and validity may be limited by the infant's behavioral state, unstable physiological status, intolerance of handling, or sternal/surgical precautions. Alternatively, European clinicians working in the field of developmental neurology realized that variation and adaptability in motor behavior may assist in the evaluation of motor development. The application of motor variation and adaptability as a means to evaluate neuromotor condition in early infancy was significant for early detection of infants at high risk for developmental problems or cerebral palsy in a number of studies with high-risk infant groups. This form of evaluation has yet to be studied in infants with complex congenital heart diseases.
The proposed study aims to study motor development of two infant groups based on oxygen saturation targets after neonatal surgery and to study the validity of the assessment tools based on the quality of movement variation and adaptability, i.e., the General Movements Assessment (GMsA) and the Infant Motor Profile (IMP) in infants with complex congenital heart disease.
Hypothesis:
Baseline oxygen saturation after neonatal heart surgery in children with complex congenital heart diseases is a determinant of motor performance outcome at 18 months on the Infant Motor Profile.
Specific Objectives:
- To determine developmental outcomes at 18 months in two infant groups based on oxygen saturation targets.
- To validate specific neuromotor assessment tools that determine developmental outcome in two infant groups based on oxygen saturation targets.
Specific Aims:
- To compare motor outcomes at 18 months measured with the IMP of two groups of infants who had surgery as neonates for complex congenital heart disease grouped by baseline oxygen saturation targets after the first surgery (≥ 90%; high saturation and < 90%; low saturation, i.e., admixed lesions).
- To describe the quality of general movements from birth through three months at five assessment points in infants with high oxygen saturation and infants with low oxygen saturation.
- To describe motor development in terms of IMP-scores at 6, 12 and 18 months in infants with high oxygen saturation and infants with low oxygen saturation.
- To explore the predictive value of GMsA at three months in a pooled group of infants with high oxygen saturation and low oxygen saturation with development outcome at 18 months assessed with:
- Infant Motor Profile (IMP)
- Alberta Infant Motor Scales (AIMS)
- Motor Composite score of the Bayley Scales of Infant Development, 3rd edition (BSID-3)
- Cognitive and Language composite scores of the BSID-3.
- To determine the concurrent validity of the Infant Motor Profile (IMP) on the basis of comparison with:
- Alberta Infant Motor Scales (AIMS) at 6, 12, and 18 months.
- Bayley Motor Composite score at 18 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Consecutive infant sampling of infants with complex congenital heart diseases
Key inclusion criteria (2 listed)
- Infants diagnosed with complex congenital heart diseases that require surgery during the neonatal period, ages 0-30 days
- Surgical care at Advocate Christ Medical Center/Advocate Children's Hospital, Oak Lawn, Il
Key exclusion criteria (1 listed)
- Chromosomal abnormalities and/or known syndromes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Motor development at 18 months
Time frame: 18 months
Comparison of motor development of two groups of infants based on oxygen saturation targets after neonatal surgery using the Infant Motor Profile
3 secondary outcomes
Movement quality from birth to 4 months of age
Time frame: 4 months. The infant's general movements are video-recorded three to five times from birth to four month according to this schedule: pre-operation (if possible), hospital discharge, one month of age, two months of age, and three months of age
Concurrent validity
Time frame: 18 months
Cognitive and language development at 18 months
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Background: PubMed 21881507Donofrio MT, Duplessis AJ, Limperopoulos C. Impact of congenital heart disease on fetal brain development and injury. Curr Opin Pediatr. 2011 Oct;23(5):502-11. doi: 10.1097/MOP.0b013e32834aa583.
- Background: PubMed 12084585Hoffman JI, Kaplan S. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-900. doi: 10.1016/s0735-1097(02)01886-7.
- Background: PubMed 17198894Brosig CL, Mussatto KA, Kuhn EM, Tweddell JS. Neurodevelopmental outcome in preschool survivors of complex congenital heart disease: implications for clinical practice. J Pediatr Health Care. 2007 Jan-Feb;21(1):3-12. doi: 10.1016/j.pedhc.2006.03.008.
- Background: PubMed 11060529Limperopoulos C, Majnemer A, Shevell MI, Rosenblatt B, Rohlicek C, Tchervenkov C. Neurodevelopmental status of newborns and infants with congenital heart defects before and after open heart surgery. J Pediatr. 2000 Nov;137(5):638-45. doi: 10.1067/mpd.2000.109152.
- Background: PubMed 20966209Hadders-Algra M. Variation and variability: key words in human motor development. Phys Ther. 2010 Dec;90(12):1823-37. doi: 10.2522/ptj.20100006. Epub 2010 Oct 21.
- Background: PubMed 15292882Hadders-Algra M. General movements: A window for early identification of children at high risk for developmental disorders. J Pediatr. 2004 Aug;145(2 Suppl):S12-8. doi: 10.1016/j.jpeds.2004.05.017.
- Background: PubMed 21711457Hamer EG, Bos AF, Hadders-Algra M. Assessment of specific characteristics of abnormal general movements: does it enhance the prediction of cerebral palsy? Dev Med Child Neurol. 2011 Aug;53(8):751-6. doi: 10.1111/j.1469-8749.2011.04007.x. Epub 2011 Jun 29.
- Derived from this study: PubMed 38091843Huisenga DC, la Bastide-van Gemert S, Van Bergen AH, Sweeney JK, Hadders-Algra M. Predictive value of General Movements Assessment for developmental delay at 18 months in children with complex congenital heart disease. Early Hum Dev. 2024 Jan;188:105916. doi: 10.1016/j.earlhumdev.2023.105916. Epub 2023 Dec 8.
- Individual participant dataSharing planned: Yes. Manuscript, Poster presentation, Conference presentation
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darlene Huisenga, PT, DPT, PCS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Defects, Congenital, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor development at 18 months (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02781545, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.