Trial Outcomes & Findings for Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach (NCT NCT04057820)

Last Updated: 2025-02-14

Results Overview

The number of days from birth until the infant is determined to be medically ready for discharge per protocol. The criteria for medical readiness were prospectively defined as an age of at least 96 hours, a period of at least 48 hours without receipt of an opioid, at least 24 hours with no respiratory support and with 100% oral feeding, and at least 24 hours from initiation of maximum caloric density.

Recruitment status

COMPLETED

Study phase

Target enrollment

1305 participants

Primary outcome timeframe

from date of birth until hospital discharge or 1 year whichever comes first

Results posted on

2025-02-14

Participant Flow

The in-hospital and initial follow-up portions of the trial were conducted with a waiver of informed consent, as approved by central institutional review board.

The in-hospital portion of the study was performed under waiver of informed consent. Only the newborn babies are considered enrolled participants. The number of participants to start a Period may not equal the number who completed a previous Period because at each subsequent Period a new cohort of newborn babies are enrolled at the respective sites. During the transition period for a given block, sites within the block are not enrolling participants.

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure	Block 1: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 1 contained four sites.	Block 1: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 1 had four sites.	Block 2: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 2 contained two sites.	Block 2: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 2 had two sites.	Block 3: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 3 contained three sites.	Block 3: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 3 had three sites.	Block 4: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 4 contained three sites.	Block 4: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 4 had threesites.	Block 5: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 5 contained four sites.	Block 5: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 5 had four sites.	Block 6: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 6 contained four sites.	Block 6: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 6 had four sites.	Block 7: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 7 contained threesites.	Block 7: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 7 had three sites.	Block 8: Usual Care, Finnegan Neonatal Abstinence Scoring Tool Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers. Block 8 contained threesites.	Block 8: Eat, Sleep, Console Care Tool New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies. Block 8 had three sites.
Period 1 STARTED	27 4	0 0	8 2	0 0	23 3	0 0	23 3	0 0	41 4	0 0	27 4	0 0	16 3	0 0	20 3	0 0
Period 1 COMPLETED	27 4	0 0	8 2	0 0	23 3	0 0	23 3	0 0	41 4	0 0	27 4	0 0	16 3	0 0	20 3	0 0
Period 1 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 2 STARTED	0 0	0 0	5 2	0 0	11 3	0 0	12 3	0 0	47 4	0 0	17 4	0 0	10 3	0 0	18 3	0 0
Period 2 COMPLETED	0 0	0 0	5 2	0 0	11 3	0 0	12 3	0 0	47 4	0 0	17 4	0 0	10 3	0 0	18 3	0 0
Period 2 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 3 STARTED	0 0	25 4	0 0	0 0	7 3	0 0	19 3	0 0	32 4	0 0	15 4	0 0	22 3	0 0	24 3	0 0
Period 3 COMPLETED	0 0	25 4	0 0	0 0	7 3	0 0	19 3	0 0	32 4	0 0	15 4	0 0	22 3	0 0	24 3	0 0
Period 3 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 4 STARTED	0 0	22 4	0 0	8 2	0 0	0 0	16 3	0 0	33 4	0 0	19 4	0 0	19 3	0 0	22 3	0 0
Period 4 COMPLETED	0 0	22 4	0 0	8 2	0 0	0 0	16 3	0 0	33 4	0 0	19 4	0 0	19 3	0 0	22 3	0 0
Period 4 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 5 STARTED	0 0	25 4	0 0	8 2	0 0	12 3	0 0	0 0	16 4	0 0	19 4	0 0	16 3	0 0	17 3	0 0
Period 5 COMPLETED	0 0	25 4	0 0	8 2	0 0	12 3	0 0	0 0	16 4	0 0	19 4	0 0	16 3	0 0	17 3	0 0
Period 5 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 6 STARTED	0 0	24 4	0 0	5 2	0 0	14 3	0 0	15 3	0 0	0 0	13 4	0 0	17 3	0 0	18 3	0 0
Period 6 COMPLETED	0 0	24 4	0 0	5 2	0 0	14 3	0 0	15 3	0 0	0 0	13 4	0 0	17 3	0 0	18 3	0 0
Period 6 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 7 STARTED	0 0	24 4	0 0	9 2	0 0	14 3	0 0	15 3	0 0	34 4	0 0	0 0	12 3	0 0	19 3	0 0
Period 7 COMPLETED	0 0	24 4	0 0	9 2	0 0	14 3	0 0	15 3	0 0	34 4	0 0	0 0	12 3	0 0	19 3	0 0
Period 7 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 8 STARTED	0 0	21 4	0 0	10 2	0 0	14 3	0 0	18 3	0 0	32 4	0 0	9 4	0 0	0 0	22 3	0 0
Period 8 COMPLETED	0 0	21 4	0 0	10 2	0 0	14 3	0 0	18 3	0 0	32 4	0 0	9 4	0 0	0 0	22 3	0 0
Period 8 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 9 STARTED	0 0	18 4	0 0	3 2	0 0	5 3	0 0	17 3	0 0	28 4	0 0	15 4	0 0	14 3	0 0	0 0
Period 9 COMPLETED	0 0	18 4	0 0	3 2	0 0	5 3	0 0	17 3	0 0	28 4	0 0	15 4	0 0	14 3	0 0	0 0
Period 9 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
Period 10 STARTED	0 0	26 4	0 0	8 2	0 0	17 3	0 0	7 3	0 0	32 4	0 0	17 4	0 0	23 3	0 0	15 3
Period 10 COMPLETED	0 0	26 4	0 0	8 2	0 0	17 3	0 0	7 3	0 0	32 4	0 0	17 4	0 0	23 3	0 0	15 3
Period 10 NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

There were 11 observations with missing maternal age in the Usual Care group while the ESC group had 2 missing maternal age values.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.	Total n=1305 Participants Total of all reporting groups
Age, Continuous	38.6 weeks STANDARD_DEVIATION 1.3 • n=702 Participants	38.6 weeks STANDARD_DEVIATION 1.3 • n=603 Participants	38.6 weeks STANDARD_DEVIATION 1.3 • n=1305 Participants
Sex: Female, Male Female	702 Participants n=702 Participants	603 Participants n=603 Participants	1305 Participants n=1305 Participants
Sex: Female, Male Male	0 Participants n=702 Participants	0 Participants n=603 Participants	0 Participants n=1305 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	107 Participants n=702 Participants	33 Participants n=603 Participants	140 Participants n=1305 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	576 Participants n=702 Participants	538 Participants n=603 Participants	1114 Participants n=1305 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=702 Participants	32 Participants n=603 Participants	51 Participants n=1305 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=702 Participants	4 Participants n=603 Participants	16 Participants n=1305 Participants
Race (NIH/OMB) Asian	2 Participants n=702 Participants	3 Participants n=603 Participants	5 Participants n=1305 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=702 Participants	11 Participants n=603 Participants	15 Participants n=1305 Participants
Race (NIH/OMB) Black or African American	104 Participants n=702 Participants	72 Participants n=603 Participants	176 Participants n=1305 Participants
Race (NIH/OMB) White	555 Participants n=702 Participants	480 Participants n=603 Participants	1035 Participants n=1305 Participants
Race (NIH/OMB) More than one race	1 Participants n=702 Participants	6 Participants n=603 Participants	7 Participants n=1305 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=702 Participants	27 Participants n=603 Participants	51 Participants n=1305 Participants
Region of Enrollment United States	702 participants n=702 Participants	603 participants n=603 Participants	1305 participants n=1305 Participants
Marital Status Married	99 Participants n=702 Participants	101 Participants n=603 Participants	200 Participants n=1305 Participants
Marital Status Single	582 Participants n=702 Participants	492 Participants n=603 Participants	1074 Participants n=1305 Participants
Marital Status Unknown	21 Participants n=702 Participants	10 Participants n=603 Participants	31 Participants n=1305 Participants
Gravidity	3 Pregnancies n=701 Participants • There was one observation in the Usual Care group with missing gravidity value.	4 Pregnancies n=603 Participants • There was one observation in the Usual Care group with missing gravidity value.	4 Pregnancies n=1304 Participants • There was one observation in the Usual Care group with missing gravidity value.
Parity	3 Births n=701 Participants • There was one observation in the Usual Care group with missing parity value.	3 Births n=603 Participants • There was one observation in the Usual Care group with missing parity value.	3 Births n=1304 Participants • There was one observation in the Usual Care group with missing parity value.
Highest Level of Education 8th grade or less	8 Participants n=702 Participants	6 Participants n=603 Participants	14 Participants n=1305 Participants
Highest Level of Education 9th grade to 12th grade	69 Participants n=702 Participants	50 Participants n=603 Participants	119 Participants n=1305 Participants
Highest Level of Education High school diploma	125 Participants n=702 Participants	99 Participants n=603 Participants	224 Participants n=1305 Participants
Highest Level of Education Partial college or Associate's degree	69 Participants n=702 Participants	50 Participants n=603 Participants	119 Participants n=1305 Participants
Highest Level of Education College degree	7 Participants n=702 Participants	9 Participants n=603 Participants	16 Participants n=1305 Participants
Highest Level of Education Trade or Technical School	2 Participants n=702 Participants	0 Participants n=603 Participants	2 Participants n=1305 Participants
Highest Level of Education Graduate degree	2 Participants n=702 Participants	3 Participants n=603 Participants	5 Participants n=1305 Participants
Highest Level of Education Unknown	420 Participants n=702 Participants	386 Participants n=603 Participants	806 Participants n=1305 Participants
Mother's Medical Insurance Public Insurance	633 participants n=702 Participants	521 participants n=603 Participants	1154 participants n=1305 Participants
Mother's Medical Insurance Private	47 participants n=702 Participants	67 participants n=603 Participants	114 participants n=1305 Participants
Mother's Medical Insurance Self-pay/uninsured	18 participants n=702 Participants	11 participants n=603 Participants	29 participants n=1305 Participants
Mother's Medical Insurance Other	0 participants n=702 Participants	3 participants n=603 Participants	3 participants n=1305 Participants
Mother's Medical Insurance Unknown	21 participants n=702 Participants	8 participants n=603 Participants	29 participants n=1305 Participants
Infant weight at birth	3026.4 g STANDARD_DEVIATION 445.4 • n=702 Participants	3012.8 g STANDARD_DEVIATION 490.4 • n=603 Participants	3020.1 g STANDARD_DEVIATION 471.8 • n=1305 Participants
Head circumference at birth	33.4 cm STANDARD_DEVIATION 1.9 • n=692 Participants • In the Usual Care group, 10 infants had missing head circumference values while 12 infants had missing observations in the ESC group.	33.5 cm STANDARD_DEVIATION 1.7 • n=591 Participants • In the Usual Care group, 10 infants had missing head circumference values while 12 infants had missing observations in the ESC group.	33.4 cm STANDARD_DEVIATION 1.8 • n=1283 Participants • In the Usual Care group, 10 infants had missing head circumference values while 12 infants had missing observations in the ESC group.
Length at birth	48.8 cm STANDARD_DEVIATION 2.6 • n=698 Participants • There were 4 infants in the Usual Care group with missing length at birth while 7 infants in the ESC group had missing observations.	48.8 cm STANDARD_DEVIATION 2.8 • n=596 Participants • There were 4 infants in the Usual Care group with missing length at birth while 7 infants in the ESC group had missing observations.	48.8 cm STANDARD_DEVIATION 2.7 • n=1294 Participants • There were 4 infants in the Usual Care group with missing length at birth while 7 infants in the ESC group had missing observations.
1-minute Apgar scores	8 Score on a scale n=689 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 1-minute evaluation is used to determine how well the infant tolerated the birthing process. There were 13 infants with missing 1-min Apgar scores in the Usual Care group while 9 infants had missing observations in the ESC group.	8 Score on a scale n=594 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 1-minute evaluation is used to determine how well the infant tolerated the birthing process. There were 13 infants with missing 1-min Apgar scores in the Usual Care group while 9 infants had missing observations in the ESC group.	8 Score on a scale n=1283 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 1-minute evaluation is used to determine how well the infant tolerated the birthing process. There were 13 infants with missing 1-min Apgar scores in the Usual Care group while 9 infants had missing observations in the ESC group.
5-minute Apgar scores	9 Score on a scale n=688 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 5-minute score measures how well the infant is doing outside the mother's womb. There were 14 infants with missing 5-min Apgar scores in the Usual Care group while 7 infants had missing observations in the ESC group.	9 Score on a scale n=596 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 5-minute score measures how well the infant is doing outside the mother's womb. There were 14 infants with missing 5-min Apgar scores in the Usual Care group while 7 infants had missing observations in the ESC group.	9 Score on a scale n=1284 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The 5-minute score measures how well the infant is doing outside the mother's womb. There were 14 infants with missing 5-min Apgar scores in the Usual Care group while 7 infants had missing observations in the ESC group.
10-minute Apgar scores	8 Score on a scale n=34 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The Usual Care group had 668 infants with missing 10-min Apgar scores while ESC had 574 missing 10-min Apgar scores.	9 Score on a scale n=29 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The Usual Care group had 668 infants with missing 10-min Apgar scores while ESC had 574 missing 10-min Apgar scores.	8 Score on a scale n=63 Participants • Apgar stands for Appearance, Pulse, Grimace, Activity and Respiration with 5 categories (breathing effort, heart rate, muscle tone, reflexes, skin color) each measured on a scale of 0, 1, 2 (range 0 to 10 with higher scores representing better outcome). The Usual Care group had 668 infants with missing 10-min Apgar scores while ESC had 574 missing 10-min Apgar scores.

PRIMARY outcome

Timeframe: from date of birth until hospital discharge or 1 year whichever comes first

Population: The primary analysis population only included those infants that met the definition of medically ready for discharge.

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=440 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=397 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Time From Birth Until Medically Ready for Discharge	14.9 days Interval 13.1 to 16.7	8.2 days Interval 7.2 to 9.2

SECONDARY outcome

Timeframe: From date of birth until hospital discharge or 1 year whichever comes first

Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Did Infant Receive Opioid Replacement Therapy (Yes/no)	328 Participants	145 Participants

SECONDARY outcome

Timeframe: From date of birth until hospital discharge or 1 year whichever comes first

Population: The analysis population for this outcome include only infants who received opioid treatment.

If infant received opioid replacement therapy, the units received (mg/kg).

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=324 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=144 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Total Dose of Opioid Replacement Therapy Infant Received	7.5 mg/kg Interval 5.0 to 10.1	5.3 mg/kg Interval 3.2 to 7.4

SECONDARY outcome

Timeframe: From date of birth until hospital discharge or 1 year whichever comes first

Population: The analysis population for this outcome include only infants who received opioid treatment.

If infant received opioid replacement therapy, the timing of the initiation of therapy

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=324 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=144 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Time Until Initiation of Opioid Replacement	53.0 hours Interval 48.7 to 57.3	76 hours Interval 63.0 to 89.0

SECONDARY outcome

Timeframe: from date of birth until hospital discharge or 1 year whichever comes first

Population: The analysis population for this outcome include only infants who received opioid treatment.

To see if the infant had to have any other type of therapy for NOWS (yes/no)

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=324 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=144 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Receipt of Adjuvant Therapy	19.4 percentage who received adjuvant therapy Interval 8.5 to 30.4	15.7 percentage who received adjuvant therapy Interval 5.5 to 25.8

SECONDARY outcome

Timeframe: from date of birth until hospital discharge or 1 year whichever comes first

Assess percent change in birthweight during hospitalization (i.e., \[minimum weight - birth weight\] / birth weight)

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Maximum Percent Change in Weight During Initial Birth Hospitalization	7.6 percentage of change in birth weight Interval 7.2 to 8.0	8.0 percentage of change in birth weight Interval 7.5 to 8.4

SECONDARY outcome

Timeframe: from date of birth until hospital discharge or 1 year whichever comes first

Exclusive maternal breast milk feeding at the time of hospital discharge

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Feeding Type at Discharge (Exclusive Maternal Breast Milk)	6.3 percentage of exclusive breast milk Interval 2.7 to 9.8	12.1 percentage of exclusive breast milk Interval 7.2 to 17.1

SECONDARY outcome

Timeframe: within 24 hours of hospital discharge

Direct breastfeeding within 24 hours of hospital discharge (yes/no)

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Any Direct Breast Feeding at Discharge	19.5 percentage of direct breast feeding Interval 15.3 to 23.7	32.7 percentage of direct breast feeding Interval 23.2 to 42.2

SECONDARY outcome

Timeframe: from date of birth until hospital discharge or 1 year whichever comes first

Time from birth until infants being managed for NOWS are discharged from the hospital

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Length of Hospital Stay	14.0 days Interval 12.7 to 15.3	7.8 days Interval 7.1 to 8.5

SECONDARY outcome

Timeframe: from date of birth until hospital discharge or 1 year whichever comes first

composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)	1 Participants	2 Participants

SECONDARY outcome

Timeframe: at 3 months of age

Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent)

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions	113 Participants	86 Participants

SECONDARY outcome

Timeframe: at 3 months of age.

any non-accidental trauma and death (yes/no)

Outcome measures

Outcome measures
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 Participants Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 Participants New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Critical Safety Outcome	5 number of non-accidental trauma/death	1 number of non-accidental trauma/death

Adverse Events

Usual Care, Finnegan Neonatal Abstinence Scoring Tool

Serious events: 4 serious events

Other events: 8 other events

Deaths: 4 deaths

Eat, Sleep, Console Care Tool

Serious events: 12 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 participants at risk Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 participants at risk New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Nervous system disorders Seizure	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Metabolism and nutrition disorders Severe Weight Loss	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Injury, poisoning and procedural complications Accidental trauma (infant dropped)	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Respiratory, thoracic and mediastinal disorders Respiratory insufficiency	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Injury, poisoning and procedural complications Accidental Drug Ingestion	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Metabolism and nutrition disorders Failure to thrive	0.28% 2/702 • Number of events 2 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Metabolism and nutrition disorders Poor weight gain	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Cardiac disorders Abnormal echocardiogram	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Infections and infestations Acute Covid-19	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Respiratory, thoracic and mediastinal disorders Tachypnea required readmission to hospital	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Congenital, familial and genetic disorders Ventricular Septal Defect	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Infections and infestations Viral Meningitis	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Gastrointestinal disorders Vomiting R11.10	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Infections and infestations Observation and evaluation of newborn sepsis	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge

Other adverse events

Other adverse events
Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n=702 participants at risk Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Finnegan Neonatal Abstinence Scoring Tool: The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Eat, Sleep, Console Care Tool n=603 participants at risk New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Eat, Sleep, Console (ESC) care tool: The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
Metabolism and nutrition disorders Severe Weight Loss	0.71% 5/702 • Number of events 5 • 3-months post-hospital discharge	2.0% 12/603 • Number of events 12 • 3-months post-hospital discharge
Injury, poisoning and procedural complications Accidental trauma (infant dropped)	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Hepatobiliary disorders Jaundice	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Infections and infestations CMV	0.00% 0/702 • 3-months post-hospital discharge	0.33% 2/603 • Number of events 2 • 3-months post-hospital discharge
Injury, poisoning and procedural complications Fall, caught before hitting floor	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Skin and subcutaneous tissue disorders Diaper Dermatitis	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Injury, poisoning and procedural complications Non-accidental trauma	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Respiratory, thoracic and mediastinal disorders PCP suspected resp. distress, not confirmed by ED	0.14% 1/702 • Number of events 1 • 3-months post-hospital discharge	0.00% 0/603 • 3-months post-hospital discharge
Gastrointestinal disorders Frequent emesis	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Nervous system disorders Neonatal sleep myoclonus	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge
Gastrointestinal disorders Attention to g-tube	0.00% 0/702 • 3-months post-hospital discharge	0.17% 1/603 • Number of events 1 • 3-months post-hospital discharge

Additional Information

Dr. Songthip Ounpraseuth

University of Arkansas for Medical Sciences

Phone: 5016867233

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place