Table 2.
Study event schedule
| 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 |
(X) Evaluations/procedures assessed under waiver of consent
(O) Evaluations/procedures performed with informed consent
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