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Table 2 Study event schedule

From: Eating, Sleeping, Consoling for Neonatal Opioid Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach study protocol for a multi-center, stepped-wedge randomized controlled trial

Evaluation/Procedures

Hospital Stay

Hospital Discharge

1 month post discharge

3 months of agea

6 months of agea

9 months of agea

12 months of agea

18 months of agea

24 months of agea

Maternal and infant medical history

X

        

Neonatal opioid withdrawal scoring/ assessments

X

        

Date/time of initiation and number of doses of opioid replacement therapy administered (Infant)

X

        

Date/time of initiation dose and number of doses of adjuvant therapy administered (Infant)

X

        

Date/time when medically ready for discharge (Infant)

X

        

Date/time discharged (Infant)

 

X

       

Weight, length and head circumference (Infant)

X

X

      

O

Feeding type (Infant)

X

X

       

Seizures, accidental trauma (i.e., dropped infants) and respiratory insufficiency (Infant)

X

X

       

Serious Adverse Events (Infant)

X

X

       

Acute/urgent care and/or ER visits and hospital readmissions

   

X

     

Non-accidental trauma & death (Infant)

 

X

 

X

    

X

Infant Behavioral Questionnaire (IBQ) – very short form (Infant)

   

O

  

O

  

Caregiver questionnaire (CQ) (enteral feeds, acute/urgent care and/or ER visits and readmissions) (Infant)

  

O

O

O

 

O

 

O

Brief Infant Sleep Questionnaire (BISQ) (Infant)

   

O

  

O

  

Patient Reported Outcome Measurement Information System (PROMIS) Short Forms (Caregiver(s))

 

O

  

O

   

O

Maternal Postnatal Attachment Questionnaire (MPAQ) (Caregiver(s))

 

O

  

O

    

Parenting Sense of Competence Scale (PSOC) (Caregiver(s))

 

O

  

O

    

Adverse Childhood Experiences (ACE) questionnaire

        

O

Family Environmental Scale (FES) – Relationship Dimension Form R (Caregiver(s))

   

O

     

Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4): Cognitive, Language and Motor

        

O

Brief Infant-Toddler Social and Emotional Assessment (BITSEA)

        

O

Contact information update

O

O

O

O

O

O

O

O

 
  1. (X) Evaluations/procedures assessed under waiver of consent
  2. (O) Evaluations/procedures performed with informed consent
  3. aProcedures occurring at ≤12 months of age may occur within ±3 weeks of stated time point. Procedures occurring at 18 and 24 months of age may occur within ±6 weeks of stated time point