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Report for D001238: Asphyxia Neonatorum NIH

(Synonyms: Asphyxia Neonatorum)

Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (3)


Name (Synonyms) Correlation
drug400 Brief Behavioral Activation Treatment Wiki 1.00
drug512 Camostat Mesilate Wiki 0.45
drug1822 Placebo Wiki 0.06

Correlated MeSH Terms (2)


Name (Synonyms) Correlation
D003866 Depressive Disorder NIH 0.24
D003863 Depression, NIH 0.15

Correlated HPO Terms (2)


Name (Synonyms) Correlation
HP:0012768 Neonatal asphyxia HPO 1.00
HP:0000716 Depressivity HPO 0.24

There is one clinical trial.

Clinical Trials


1 Scaling Up Maternal Mental Health Care by Increasing Access to Treatment (SUMMIT): A Study Protocol for Perinatal Depression and Anxiety

SUMMIT (Scaling Up Maternal Mental health care by Increasing access to Treatment) overarching goal is to examine the scalability and patient-centered provision of brief, evidence-based psychological treatments for perinatal depression and anxiety (N=1368). Specifically, and through a multi-site, randomized, pragmatic trial, the trial examines whether one brief, behavioral activation (BA) delivered via telemedicine is as effective as the same treatment delivered in person; and whether BA delivered by non-mental health nurses, with appropriate training is as effective as when delivered by specialist providers (psychiatrists, psychologists and social workers) in reducing perinatal depressive and anxiety symptoms. The study will be conducted in Toronto, Chicago and North Carolina. The trial will also identify relevant underlying implementation processes and determine whether, and to what extent, these strategies work differentially for certain women over others.

NCT04153864 Perinatal Depression Behavioral: Brief Behavioral Activation Treatment
MeSH:Asphyxia Neonatorum Depression Depressive Disorder
HPO:Depressivity Neonatal asphyxia

Primary Outcomes

Description: Brief BA psychological treatment is delivered by non-specialist providers. The perinatal depressive symptoms are measured by the Edinburgh Postnatal Depression Scale. The minimum and maximum values for the Edinburgh Postnatal Depression Scale are 0 and 30 respectively. Higher scale scores are associated with higher perinatal depressive symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal depressive symptoms by non-specialist providers

Time: 3-months post-randomization

Description: Brief BA psychological treatment is delivered through telemedicine. The perinatal depressive symptoms are measured by the Edinburgh Postnatal Depression Scale. The minimum and maximum values for the Edinburgh Postnatal Depression Scale are 0 and 30 respectively. Higher scale scores are associated with higher perinatal depressive symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal depressive symptoms through telemedicine

Time: 3-months post-randomization

Secondary Outcomes

Description: Brief BA psychological treatment is delivered by non-specialist providers. The anxiety symptoms are measured by the Generalized Anxiety 7 Item Questionnaire. The minimum and maximum values for the Generalized Anxiety 7 Item Questionnaire are 0 and 21 respectively. Higher scale scores are associated with higher perinatal anxiety symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal anxiety symptoms by non-specialist providers

Time: 3-months post-randomization

Description: Brief BA psychological treatment is delivered through telemedicine. The anxiety symptoms are measured by the Generalized Anxiety 7 Item Questionnaire. The minimum and maximum values for the Generalized Anxiety 7 Item Questionnaire are 0 and 21 respectively. Higher scale scores are associated with higher perinatal anxiety symptoms. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Treatment of perinatal anxiety symptoms through telemedicine

Time: 3-months post-randomization

Description: Child mental development is measured by Bayley Mental Developmental Scale III and the provision of psychosocial stimulation by the mother measured by Home Observation Measurement Evaluation. Cognitive development, expressive and receptive language, and fine and gross motor development composite scores are measured by Bayley Mental Developmental Scale III. The composite scores are scaled to a metric, with a mean of 100, standard deviation of 15, and range of 40 to 160. Higher scaled scores are associated with higher mental health development in child. The minimum and maximum values for the Home Observation Measurement Evaluation scale scores are 0 and 45 respectively. Higher scores are associated with more enriched environment.

Measure: Child Mental Health Development

Time: 9 to 12 months post child birth

Description: Response and Remission is measured by Patient Health Questionnaire 9. The minimum and maximum values for Patient Health Questionnaire 9 are 0 and 27 respectively. Response and Remission is defined as PHQ-9 of less than 10 and 5 respectively. The assessment period is extended to account for post-treatment outcomes when there are interruptions to treatment (e.g., giving birth or obstetrical events).

Measure: Response and Remission

Time: 3-months post-randomization


HPO Nodes