Trial Outcomes & Findings for Genomic Sequencing for Childhood Risk and Newborn Illness (NCT NCT02422511)

Last Updated: 2024-04-03

Results Overview

Days spent in inpatient care from disclosure of randomization status / genomic sequencing results through 10 months post-disclosure. Services were identified through a combination of chart note review, medical record review and participant surveys.

Recruitment status

COMPLETED

Study phase

Target enrollment

1205 participants

Primary outcome timeframe

From disclosure through 10 Months post-disclosure (approx. 15 months after baseline).

Results posted on

2024-04-03

Participant Flow

Participant milestones

Participant milestones
Measure	Well Baby Parents: Family History Only Parents of newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report tand reviewed with all participants.	Well Babies: Family History Only Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report tand reviewed with all participants.	Well Baby Parents: Family History + Exome Sequencing Parents of newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled. Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants.	Well Babies: Family History + Exome Sequencing Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled. Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants.	ICU Baby Parents: Family History Only Parents of newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants.	ICU Babies: Family History Only Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only. Parents and their newborns are enrolled. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants.	ICU Baby Parents: Family History + Exome Sequencing Parents of newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled. Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants.	ICU Babies: Family History + Exome Sequencing Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report. Parents and their newborns are enrolled. Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing receive a 'Genomic Newborn Sequencing Report' (GNSR) which includes pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study have a family history taken by a study genetic counselor. Information collected through the family history is summarized in a family history report that is reviewed with all participants.
Overall Study STARTED	255	128	257	129	66	33	68	34
Overall Study Received Disclosure	158	79	194	97	43	21	38	19
Overall Study COMPLETED	143	0	168	0	39	0	38	0
Overall Study NOT COMPLETED	112	128	89	129	27	33	30	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Genomic Sequencing for Childhood Risk and Newborn Illness

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Well Baby Parents: Family History Only n=255 Participants Parents of newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Well Babies: Family History Only n=128 Participants Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Well Baby Parents: Family History + Exome Sequencing n=257 Participants Parents of newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Well Babies: Family History + Exome Sequencing n=129 Participants Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Parents: Family History Only n=66 Participants Parents of newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Babies: Family History Only n=33 Participants Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Parents: Family History + Exome Sequencing n=68 Participants Parents of newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Babies: Family History + Exome Sequencing n=34 Participants Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Total n=970 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	128 Participants n=7 Participants	0 Participants n=5 Participants	129 Participants n=4 Participants	0 Participants n=21 Participants	33 Participants n=8 Participants	0 Participants n=8 Participants	34 Participants n=24 Participants	324 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	255 Participants n=5 Participants	0 Participants n=7 Participants	257 Participants n=5 Participants	0 Participants n=4 Participants	66 Participants n=21 Participants	0 Participants n=8 Participants	68 Participants n=8 Participants	0 Participants n=24 Participants	646 Participants n=42 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Continuous	34 years STANDARD_DEVIATION 4.45 • n=5 Participants	.025 years STANDARD_DEVIATION .016 • n=7 Participants	35 years STANDARD_DEVIATION 4.60 • n=5 Participants	.027 years STANDARD_DEVIATION .017 • n=4 Participants	32 years STANDARD_DEVIATION 5.29 • n=21 Participants	.055 years STANDARD_DEVIATION .039 • n=8 Participants	35 years STANDARD_DEVIATION 5.38 • n=8 Participants	.060 years STANDARD_DEVIATION .031 • n=24 Participants	34 years STANDARD_DEVIATION 4.75 • n=42 Participants
Sex: Female, Male Female	130 Participants n=5 Participants	66 Participants n=7 Participants	129 Participants n=5 Participants	63 Participants n=4 Participants	33 Participants n=21 Participants	15 Participants n=8 Participants	34 Participants n=8 Participants	17 Participants n=24 Participants	487 Participants n=42 Participants
Sex: Female, Male Male	125 Participants n=5 Participants	62 Participants n=7 Participants	128 Participants n=5 Participants	66 Participants n=4 Participants	33 Participants n=21 Participants	18 Participants n=8 Participants	34 Participants n=8 Participants	17 Participants n=24 Participants	483 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	20 Participants n=5 Participants	15 Participants n=7 Participants	9 Participants n=5 Participants	9 Participants n=4 Participants	7 Participants n=21 Participants	5 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	67 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	196 Participants n=5 Participants	88 Participants n=7 Participants	212 Participants n=5 Participants	107 Participants n=4 Participants	55 Participants n=21 Participants	25 Participants n=8 Participants	64 Participants n=8 Participants	30 Participants n=24 Participants	777 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants n=5 Participants	25 Participants n=7 Participants	36 Participants n=5 Participants	13 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	126 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	2 Participants n=42 Participants
Race (NIH/OMB) Asian	28 Participants n=5 Participants	10 Participants n=7 Participants	31 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants	1 Participants n=24 Participants	84 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants	2 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	37 Participants n=42 Participants
Race (NIH/OMB) White	194 Participants n=5 Participants	89 Participants n=7 Participants	185 Participants n=5 Participants	79 Participants n=4 Participants	57 Participants n=21 Participants	27 Participants n=8 Participants	57 Participants n=8 Participants	27 Participants n=24 Participants	715 Participants n=42 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants	12 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	55 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	15 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants	16 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	4 Participants n=8 Participants	2 Participants n=24 Participants	74 Participants n=42 Participants
Region of Enrollment United States	255 participants n=5 Participants	128 participants n=7 Participants	257 participants n=5 Participants	129 participants n=4 Participants	66 participants n=21 Participants	33 participants n=8 Participants	69 participants n=8 Participants	34 participants n=24 Participants	647 participants n=42 Participants

PRIMARY outcome

Timeframe: From disclosure through 10 Months post-disclosure (approx. 15 months after baseline).

Population: The analysis population included infants enrolled in the BabySeq project. Data was not available for all participants due to withdrawal or non-responsiveness to follow up surveys.

Outcome measures

Outcome measures
Measure	Well Baby Family History Only n=116 Participants Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Well Baby Family History + Exome Sequencing n=121 Participants Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Family History Only n=31 Participants Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Family History + Exome Sequencing n=30 Participants Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.
Downstream Health Care Costs Attributable to BabySeq Project Disclosure: Days of Inpatient Care	0.1 Days Standard Deviation 0.4	0.0 Days Standard Deviation 0.3	3.1 Days Standard Deviation 12.9	3.8 Days Standard Deviation 12.9

PRIMARY outcome

Timeframe: From baseline through 10 post-disclosure, with time points varying by measure. (Post-disclosure approx. 5 months after baseline; 3-months approx. 8 months after baseline; 10-months approx. 15 months after baseline)

Population: The analysis population included parents of infants enrolled in the BabySeq project. Data was not available for all participants due to withdrawal or non-responsiveness to follow up surveys.

Parents' Distress was assessed using validated scales measuring Anxiety and Depression, and a novel item assessing Blame with responses ranging from 1 to 5. Higher scores indicate more distress. Anxiety per the Edinburgh Postnatal Depression Scale anxiety subscale (baseline, post-disclosure, and 3 months; scores ranging from 0 to 9); Anxiety per the Generalized Anxiety Disorder Scale-7 (3 months and 10 months; scores ranging from 0 to 21); Depression per the Edinburgh Postnatal Depression Scale (baseline, post-disclosure, and 3 months; scores ranging from 0 to 30); Depression per the Patient Health Questionnaire-9 (3 months and 10 months; scores ranging from 0 to 30); Self-blame per a novel item (3 months and 10 months)

Outcome measures

Outcome measures
Measure	Well Baby Family History Only n=202 Participants Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Well Baby Family History + Exome Sequencing n=203 Participants Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Family History Only n=53 Participants Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Family History + Exome Sequencing n=60 Participants Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.
Parents' Distress Anxiety per the Generalized Anxiety Disorder Scale-7 - 3 months	2.4 score on a scale Standard Deviation 2.99	2.47 score on a scale Standard Deviation 2.83	3.34 score on a scale Standard Deviation 3.77	3.72 score on a scale Standard Deviation 4.52
Parents' Distress Anxiety per the Edinburgh Postnatal Depression Scale anxiety subscale - baseline	2.6 score on a scale Standard Deviation 1.83	2.75 score on a scale Standard Deviation 1.83	3.04 score on a scale Standard Deviation 2.1	3.28 score on a scale Standard Deviation 2.05
Parents' Distress Anxiety per the Edinburgh Postnatal Depression Scale anxiety subscale - Postdisclosure	2.19 score on a scale Standard Deviation 1.86	2.34 score on a scale Standard Deviation 1.91	2.44 score on a scale Standard Deviation 2.29	2.56 score on a scale Standard Deviation 1.83
Parents' Distress Anxiety per the Edinburgh Postnatal Depression Scale anxiety subscale - 3 months	1.86 score on a scale Standard Deviation 1.87	1.97 score on a scale Standard Deviation 1.86	2.16 score on a scale Standard Deviation 2.07	2.24 score on a scale Standard Deviation 1.83
Parents' Distress Anxiety per the Generalized Anxiety Disorder Scale-7 - 10 months	2.46 score on a scale Standard Deviation 3.06	2.77 score on a scale Standard Deviation 3.10	3.43 score on a scale Standard Deviation 4.2	2.25 score on a scale Standard Deviation 2.92
Parents' Distress Depression per the Edinburgh Postnatal Depression Scale - baseline	4.68 score on a scale Standard Deviation 3.62	4.96 score on a scale Standard Deviation 3.64	6.51 score on a scale Standard Deviation 4.69	6.69 score on a scale Standard Deviation 4.72
Parents' Distress Depression per the Edinburgh Postnatal Depression Scale - 3 months	3.53 score on a scale Standard Deviation 3.45	3.96 score on a scale Standard Deviation 3.68	5.13 score on a scale Standard Deviation 4.90	4.54 score on a scale Standard Deviation 4.33
Parents' Distress Depression per the Patient Health Questionnaire-9 - 3 months	4.04 score on a scale Standard Deviation 3.47	3.49 score on a scale Standard Deviation 2.79	4.86 score on a scale Standard Deviation 5.93	4.35 score on a scale Standard Deviation 3.20
Parents' Distress Depression per the Patient Health Questionnaire-9 - 10 months	3.79 score on a scale Standard Deviation 3.04	3.96 score on a scale Standard Deviation 3.21	5.20 score on a scale Standard Deviation 6.25	4.42 score on a scale Standard Deviation 3.05
Parents' Distress novel item assessing Blame - 3 months	1.8 score on a scale Standard Deviation 0.83	1.96 score on a scale Standard Deviation 0.90	2.12 score on a scale Standard Deviation 0.93	1.97 score on a scale Standard Deviation 0.811
Parents' Distress Depression per the Edinburgh Postnatal Depression Scale - postdisclosure	4.12 score on a scale Standard Deviation 3.51	4.38 score on a scale Standard Deviation 3.85	5.0 score on a scale Standard Deviation 5.03	4.92 score on a scale Standard Deviation 4.54
Parents' Distress novel item assessing Blame - 10 months	1.95 score on a scale Standard Deviation 0.89	1.78 score on a scale Standard Deviation 0.86	2.39 score on a scale Standard Deviation 1.10	1.87 score on a scale Standard Deviation 0.70

PRIMARY outcome

Parent-Child Relationship was assessed using validated scales measuring parents' perceptions of parenting stress (General parenting stress per the Parenting Stress Index™, 4th Edition Short Form (10 months); scores range from 36 to 180), how vulnerable they perceive their child to be (Parents' perception of baby's vulnerability per the Vulnerable Baby Scale (baseline, postdisclosure, 3 months, 10 months); scores range from 4 to 20), and how they are bonding with their child (Parent-child bonding per the Mother-to-Infant Bonding Scale (baseline, postdisclosure, 3 months, 10 months); scores range from 0 to 24). Lower bonding scores indicate more problems with bonding. For other measures, higher scores indicate higher stress and perceptions of vulnerability.

Outcome measures

Outcome measures
Measure	Well Baby Family History Only n=212 Participants Newborns in well-baby units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	Well Baby Family History + Exome Sequencing n=212 Participants Newborns in well-baby units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Family History Only n=54 Participants Newborns in intensive care units receive an Annotated Family History Report only. Active Comparator: Standard of Care Only: Family History report only Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.	ICU Baby Family History + Exome Sequencing n=63 Participants Newborns in intensive care units receive a Genome Report and an Annotated Family History Report. Main Study Experimental: Genome Report and Family History report Genomic sequencing: Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease. Family history report: Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.
Parent-Child Relationship Parent-child bonding per the Mother-to-Infant Bonding Scale - postdisclosure	1.18 score on a scale Standard Deviation 1.64	1.15 score on a scale Standard Deviation 1.45	1.05 score on a scale Standard Deviation 1.25	0.95 score on a scale Standard Deviation 1.21
Parent-Child Relationship Parent-child bonding per the Mother-to-Infant Bonding Scale - 3 months	1.48 score on a scale Standard Deviation 1.79	1.36 score on a scale Standard Deviation 1.63	1.56 score on a scale Standard Deviation 1.90	1.03 score on a scale Standard Deviation 1.36
Parent-Child Relationship Parent-child bonding per the Mother-to-Infant Bonding Scale - 10 months	1.47 score on a scale Standard Deviation 1.81	1.45 score on a scale Standard Deviation 1.81	1.74 score on a scale Standard Deviation 3.14	1.30 score on a scale Standard Deviation 1.57
Parent-Child Relationship Vulnerable Baby Scale - baseline	9.02 score on a scale Standard Deviation 2.82	9.11 score on a scale Standard Deviation 2.82	13.01 score on a scale Standard Deviation 3.88	13.54 score on a scale Standard Deviation 3.58
Parent-Child Relationship Vulnerable Baby Scale - postdisclosure	8.03 score on a scale Standard Deviation 2.44	8.59 score on a scale Standard Deviation 2.79	10.24 score on a scale Standard Deviation 3.37	11.55 score on a scale Standard Deviation 3.72
Parent-Child Relationship Vulnerable Baby Scale - 3 months	8.17 score on a scale Standard Deviation 2.63	8.27 score on a scale Standard Deviation 2.79	9.77 score on a scale Standard Deviation 3.61	9.84 score on a scale Standard Deviation 3.32
Parent-Child Relationship Vulnerable Baby Scale - 10 months	7.3 score on a scale Standard Deviation 2.3	7.46 score on a scale Standard Deviation 2.32	8.51 score on a scale Standard Deviation 3.06	9.21 score on a scale Standard Deviation 3.14
Parent-Child Relationship Parent-child bonding per the Mother-to-Infant Bonding Scale - baseline	1.6 score on a scale Standard Deviation 1.83	1.35 score on a scale Standard Deviation 1.82	1.45 score on a scale Standard Deviation 1.76	1.71 score on a scale Standard Deviation 1.65
Parent-Child Relationship Parenting Stress Index™, 4th Edition Short Form- 10 months	61.17 score on a scale Standard Deviation 18.19	60.46 score on a scale Standard Deviation 15.55	64.94 score on a scale Standard Deviation 19.15	62.03 score on a scale Standard Deviation 15.11

PRIMARY outcome

Timeframe: From baseline through 10 post-disclosure, with time points varying by measure. Post-disclosure approx. 5 months after baseline; 3-months approx. 8 months after baseline; 10-months approx. 15 months after baseline.

Parents' Relationship was assessed using validated and novel measures of marital satisfaction using the Relationship satisfaction per the Kansas Marital Satisfaction Scale (3 months; scores ranging from 3 to 15), relationship conflict per a novel item (all time points; scores ranging from 1 to 5), and partner blame per a novel item (3 months and 10 months; scores ranging from 1 to 5). Higher scores on Satisfaction indicates more Satisfaction. Higher scores on Conflict and Blame indicate higher conflict and blame.