Neonatal Opiate Withdrawal Syndrome(ESC-NOW)NCT04057820

Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach

A study testing Finnegan Neonatal Abstinence Scoring Tool and Eat, Sleep, Console (ESC) care tool in people with Neonatal Opiate Withdrawal Syndrome, run by Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) Program at 26 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge. Read more about this study

Who is it for?: Ages Up to 3 days
Conditions the study is for: Neonatal Opiate Withdrawal Syndrome
What is being tested?: Finnegan Neonatal Abstinence Scoring Tool and Eat, Sleep, Console (ESC) care tool
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,305 participants
Where: 26 sitesUnited States
Study dates: 8 Sep 2020to 24 Sep 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 3 days
All sexes
No healthy volunteers
Child

Who may be able to join

1. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:
Maternal history of prenatal opioid use
Maternal toxicology screen positive for opioids during the second and/or third trimester of pregnancy
Infant toxicology screen positive for opioids during the initial hospital stay

Who cannot join

1. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital

Trial locations and contacts

26 sites in 1 country.

City, postcode or hospital

26 sites in 1 country

United States26 sites

University of New Mexico
Albuquerque, New Mexico, 87106
University of Buffalo
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
Good Samaritan Hospital
Cincinnati, Ohio, 45220
University of Cincinnati
Cincinnati, Ohio, 45229
Case Western Reserve University
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43215
Duke Hospital
Durham, North Carolina, 27710
St. Elizabeth Healthcare/CCHMC
Edgewood, Kentucky, 41017
Kapiolani Hospital
Honolulu, Hawaii, 96826
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Kansas University Medical Center
Kansas City, Kansas, 66160
Norton Children's Hospital
Louisville, Kentucky, 40202
Tulane University School of Medicine
Metairie, Louisiana, 70001
Chistiana Care Health Systems
Newark, Delaware, 19718
Oklahoma University Health Sciences Center
Oklahoma City, Oklahoma, 73104
University of Nebraska Medical Center
Omaha, Nebraska, 68198-1205
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
University of Rochester
Rochester, New York, 14642
University of Utah Medical Center
Salt Lake City, Utah, 84108
Shawnee Mission Medical Center
Shawnee Mission, Kansas, 66204
Sanford Health
Sioux Falls, South Dakota, 57105
Spartanburg Regional Medical Center
Spartanburg, South Carolina, 29303
Tampa General Hospital
Tampa, Florida, 33606
Winchester Hospital
Winchester, Massachusetts, 01890

Other trials in United States

About this study

The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.

Read the detailed description

This study will randomize institutions in blocks to transition from usual institutional care for infants with NOWS to the ESC care approach at a randomly allocated transition period (from usual care to the ESC care approach).

During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.

The site research team will obtain informed consent from the legal guardian(s) to obtain long-term outcomes for eligible infants and caregivers. Clinical site research team members may obtain this consent at any point during the hospital stay for infants who meet the trial's inclusion criteria. This data will allow the protocol study team to short- and long-term outcomes for infants managed with the ESC care approach compared to usual institutional care.

Conditions: Neonatal Opiate Withdrawal Syndrome
Being tested: Finnegan Neonatal Abstinence Scoring Tool, Eat, Sleep, Console (ESC) care tool
Keywords: NOWS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Finnegan Neonatal Abstinence Scoring ToolOther
Also called FNAST
The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.
Eat, Sleep, Console (ESC) care toolOther
Also called ESC
The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.

Study groups in NCT04057820
Study group	Role	What they receive
Usual care, Finnegan Neonatal Abstinence Scoring Tool	Active comparator	Usual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) Receives: Other: Finnegan Neonatal Abstinence Scoring Tool
Eat, Sleep, Console care tool	Active comparator	New treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool Receives: Other: Eat, Sleep, Console (ESC) care tool

What is being measured

The primary outcome is the main question the study is designed to answer.

Time From Birth Until Medically Ready for Discharge
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.
Measured: from date of birth until hospital discharge or 1 year whichever comes first

Secondary outcomes (11)

Did Infant Receive Opioid Replacement Therapy (Yes/no)
Review of hospital records to determine if infant received opioid replacement therapy prior to hospital discharge
Measured: From date of birth until hospital discharge or 1 year whichever comes first
Total Dose of Opioid Replacement Therapy Infant Received
If infant received opioid replacement therapy, the units received (mg/kg).
Measured: From date of birth until hospital discharge or 1 year whichever comes first
Time Until Initiation of Opioid Replacement
If infant received opioid replacement therapy, the timing of the initiation of therapy
Measured: From date of birth until hospital discharge or 1 year whichever comes first
Receipt of Adjuvant Therapy
To see if the infant had to have any other type of therapy for NOWS (yes/no)
Measured: from date of birth until hospital discharge or 1 year whichever comes first
Maximum Percent Change in Weight During Initial Birth Hospitalization
Assess percent change in birthweight during hospitalization (i.e., [minimum weight - birth weight] / birth weight)
Measured: from date of birth until hospital discharge or 1 year whichever comes first
Feeding Type at Discharge (Exclusive Maternal Breast Milk)
Exclusive maternal breast milk feeding at the time of hospital discharge
Measured: from date of birth until hospital discharge or 1 year whichever comes first
Any Direct Breast Feeding at Discharge
Direct breastfeeding within 24 hours of hospital discharge (yes/no)
Measured: within 24 hours of hospital discharge
Length of Hospital Stay
Time from birth until infants being managed for NOWS are discharged from the hospital
Measured: from date of birth until hospital discharge or 1 year whichever comes first
Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)
composite of the following: seizures, accidental trauma, respiratory insufficiency due to opioid therapy
Measured: from date of birth until hospital discharge or 1 year whichever comes first
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions
Outpatient composite safety outcome which includes acute/urgent care and/or emergency room visits, hospital readmissions at 3 months (present/absent)
Measured: at 3 months of age
Critical Safety Outcome
any non-accidental trauma and death (yes/no)
Measured: at 3 months of age.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 202024 Sep 2024

First posted15 Aug 2019
Study start8 Sep 2020
Primary completion11 May 2022
Study completion24 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Neonatal Opiate Withdrawal SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Model description: Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,305 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04057820
Sponsor's protocol ID: ACTNOW-01
Other IDs: 3U2COD023375-06S1
Acronym: (ESC-NOW)
Status last verified: Jan 2025
First submitted: 9 Aug 2019
Last updated: 14 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Beauman SGS, Hu Z, Rice W, Devlin L, Merhar SL, Fung CM, Brown J, Osman A, Pahl A, Ramsey KW, Whalen B, MacMillan KDL, Ounpraseuth ST, Das A, Crawford MM, Trochinski L, Greenberg RG, Smith PB, Young LW, Maxwell JR; Eunice Kennedy Shriver NICHD Neonatal Research Network and the NIH ECHO Program IDeA States Pediatrics Clinical Trials Network. Antenatal Exposure to Medication for Opioid Use Disorder and Infant Outcomes in the Eat, Sleep, Console for Neonatal Opioid Withdrawal Randomized Controlled Trial. J Pediatr. 2026 Feb;289:114859. doi: 10.1016/j.jpeds.2025.114859. Epub 2025 Oct 17.
PubMed 41110632
Merhar SL, Hu Z, Devlin LA, Ounpraseuth ST, Simon AE, Smith PB, Walsh MC, Lee JY, Das A, Higgins RD, Crawford MM, Rice W, Paul DA, Maxwell JR, Telang SD, Fung CM, Wright T, Reynolds AM, Hahn D, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Tri; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Trials Network. Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2024 Oct 1;178(10):976-984. doi: 10.1001/jamapediatrics.2024.2578.
PubMed 39133505
Devlin LA, Hu Z, Merhar SL, Ounpraseuth ST, Simon AE, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Fung CM, Wright T, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver NICHD Neonatal Research Network and NIH Environmental Influences on Child Health Outcomes (ECHO) Program Institutional Development Award States Pediatric Clinical Trials Network. Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial. JAMA Pediatr. 2024 Jun 1;178(6):525-532. doi: 10.1001/jamapediatrics.2024.0544.
PubMed 38619854
Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.
PubMed 37125831

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Cerebral Physiology of NOWS
Neonatal Opioid Withdrawal, Neonatal Opioid Withdrawal Syndrome
Active, not recruitingPhase 3
Trial to Shorten Pharmacologic Treatment of Newborns With Neonatal Opioid Withdrawal Syndrome (NOWS)
Neonatal Opioid Withdrawal Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
RecruitingObservational study
Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome

All Neonatal Opiate Withdrawal Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Eating, Sleeping, Consoling for Neonatal Withdrawal (ESC-NOW): a Function-Based Assessment and Management Approach
ClinicalTrials.gov ID: NCT04057820
Acronym / sponsor ID: (ESC-NOW) / ACTNOW-01
Conditions: Neonatal Opiate Withdrawal Syndrome
Keywords: NOWS
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,305 participants (actual)
Lead sponsor: Advancing Clinical Trials in Neonatal Opioid Withdrawal (ACT NOW) ProgramResearch network
Collaborators: National Institutes of Health (NIH)
Study start: 8 Sep 2020 (actual)
Primary completion: 11 May 2022 (actual)
Study completion: 24 Sep 2024 (actual)
First posted: 15 Aug 2019 (actual)
Results: Posted 4 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The overall objective is to determine if the ESC care approach will reduce the time until infants being managed for NOWS are medically ready for discharge.

Detailed description

During the initial birth hospitalization, the clinical site research team will collect data under waiver of consent for infants who meet eligibility criteria.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Stepped-wedge cluster randomized controlled trial with transition period.All sites start with usual care and are transitioned to using the ESC tool

Arm	Type	Receives
Usual care, Finnegan Neonatal Abstinence Scoring Tool	Active comparator	Other: Finnegan Neonatal Abstinence Scoring ToolUsual institutional care for infants with NOWS with the Finnegan Neonatal Abstinence Scoring Tool (FNAST)
Eat, Sleep, Console care tool	Active comparator	Other: Eat, Sleep, Console (ESC) care toolNew treatment implemented at the site for infants with NOWS using the Eat, Sleep, Console (ESC) care tool

Who may qualify

Ages: Up to 3 days
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (4 listed)

1. The infant is being managed for NOWS at an eligible site (i.e., receiving non-pharmacologic care, assessments for withdrawal severity, +/- pharmacologic care) 2. The infant is ≥ 36 weeks gestation 3. The infant satisfies at least 1 of the following criteria:

Key exclusion criteria (1 listed)

1. Infant has major birth defect(s) 2. Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed by 60 hours of life 3. Infant was receiving respiratory support (any positive pressure or oxygen therapy) unrelated to pharmacologic treatment for NOWS at 60 hours of life 4. Infant was receiving antimicrobial(s) at 60 hours of life 5. Infant has received any major surgical intervention in the first 60 hours of life 6. Postnatal opioid exposure other than for treatment of NOWS in the first 60 hours of life 7. Outborn infants transferred at >60 hours of life or treated with opioids for NOWS at the transferring hospital

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Finnegan Neonatal Abstinence Scoring ToolAlso: FNASTThe FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.	Other	Usual care, Finnegan Neonatal Abstinence Scoring Tool
Eat, Sleep, Console (ESC) care toolAlso: ESCThe ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.	Other	Eat, Sleep, Console care tool

Primary outcome

Time From Birth Until Medically Ready for Discharge
Time frame: from date of birth until hospital discharge or 1 year whichever comes first
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.

11 secondary outcomes

Did Infant Receive Opioid Replacement Therapy (Yes/no)
Time frame: From date of birth until hospital discharge or 1 year whichever comes first
Total Dose of Opioid Replacement Therapy Infant Received
Time frame: From date of birth until hospital discharge or 1 year whichever comes first
Time Until Initiation of Opioid Replacement
Time frame: From date of birth until hospital discharge or 1 year whichever comes first
Receipt of Adjuvant Therapy
Time frame: from date of birth until hospital discharge or 1 year whichever comes first
Maximum Percent Change in Weight During Initial Birth Hospitalization
Time frame: from date of birth until hospital discharge or 1 year whichever comes first
Feeding Type at Discharge (Exclusive Maternal Breast Milk)
Time frame: from date of birth until hospital discharge or 1 year whichever comes first
Any Direct Breast Feeding at Discharge
Time frame: within 24 hours of hospital discharge
Length of Hospital Stay
Time frame: from date of birth until hospital discharge or 1 year whichever comes first
Inpatient Composite Safety Outcome Which Includes Seizures, Accidental Trauma, Respiratory Insufficiency Due to Opioid Therapy (Present/Absent)
Time frame: from date of birth until hospital discharge or 1 year whichever comes first
Composite of the Following: Acute/Urgent Care and/or Emergency Room Visits, Hospital Readmissions
Time frame: at 3 months of age
Critical Safety Outcome
Time frame: at 3 months of age.

Results and safety

Results posted to the registry on 4 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Block 1: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	27	27
Block 1: Eat, Sleep, Console Care Tool	0	0
Block 2: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	8	8
Block 2: Eat, Sleep, Console Care Tool	0	0
Block 3: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	23	23
Block 3: Eat, Sleep, Console Care Tool	0	0
Block 4: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	23	23
Block 4: Eat, Sleep, Console Care Tool	0	0
Block 5: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	41	41
Block 5: Eat, Sleep, Console Care Tool	0	0
Block 6: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	27	27
Block 6: Eat, Sleep, Console Care Tool	0	0
Block 7: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	16	16
Block 7: Eat, Sleep, Console Care Tool	0	0
Block 8: Usual Care, Finnegan Neonatal Abstinence Scoring Tool	20	20
Block 8: Eat, Sleep, Console Care Tool	0	0

Primary outcome: Time From Birth Until Medically Ready for Discharge

Time frame: from date of birth until hospital discharge or 1 year whichever comes first. Least squares mean (95% Confidence Interval). Unit: days

Measure	Usual Care, Finnegan Neonatal Abstinence Scoring Tool n = 440	Eat, Sleep, Console Care Tool n = 397
Value	14.9 (13.1 to 16.7)	8.2 (7.2 to 9.2)

Usual Care, Finnegan Neonatal Abstinence Scoring Tool vs Eat, Sleep, Console Care Tool: Incidence rate ratio (IRR): 0.55 (95% CI 0.46 to 0.65), p <0.0001, Mixed Models Analysis

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

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3-months post-hospital discharge. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Usual Care, Finnegan Neonatal Abstinence Scoring Tool	4 of 702 (0.6%)	8 of 702 (1.1%)	4 of 702
Eat, Sleep, Console Care Tool	12 of 603 (2%)	18 of 603 (3%)	0 of 603

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 41110632Beauman SGS, Hu Z, Rice W, Devlin L, Merhar SL, Fung CM, Brown J, Osman A, Pahl A, Ramsey KW, Whalen B, MacMillan KDL, Ounpraseuth ST, Das A, Crawford MM, Trochinski L, Greenberg RG, Smith PB, Young LW, Maxwell JR; Eunice Kennedy Shriver NICHD Neonatal Research Network and the NIH ECHO Program IDeA States Pediatrics Clinical Trials Network. Antenatal Exposure to Medication for Opioid Use Disorder and Infant Outcomes in the Eat, Sleep, Console for Neonatal Opioid Withdrawal Randomized Controlled Trial. J Pediatr. 2026 Feb;289:114859. doi: 10.1016/j.jpeds.2025.114859. Epub 2025 Oct 17.
Derived from this study: PubMed 39133505Merhar SL, Hu Z, Devlin LA, Ounpraseuth ST, Simon AE, Smith PB, Walsh MC, Lee JY, Das A, Higgins RD, Crawford MM, Rice W, Paul DA, Maxwell JR, Telang SD, Fung CM, Wright T, Reynolds AM, Hahn D, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Tri; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network National Institutes of Health Environmental Influences on Child Health Outcomes Program Institutional Development Award States Pediatric Clinical Trials Network. Infant Feeding and Weight Trajectories in the Eat, Sleep, Console Trial: A Secondary Analysis of a Randomized Clinical Trial. JAMA Pediatr. 2024 Oct 1;178(10):976-984. doi: 10.1001/jamapediatrics.2024.2578.
Derived from this study: PubMed 38619854Devlin LA, Hu Z, Merhar SL, Ounpraseuth ST, Simon AE, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Fung CM, Wright T, Ross J, McAllister JM, Crowley M, Shaikh SK, Christ L, Brown J, Riccio J, Wong Ramsey K, Braswell EF, Tucker L, McAlmon K, Dummula K, Weiner J, White JR, Newman S, Snowden JN, Young LW; Eunice Kennedy Shriver NICHD Neonatal Research Network and NIH Environmental Influences on Child Health Outcomes (ECHO) Program Institutional Development Award States Pediatric Clinical Trials Network. Influence of Eat, Sleep, and Console on Infants Pharmacologically Treated for Opioid Withdrawal: A Post Hoc Subgroup Analysis of the ESC-NOW Randomized Clinical Trial. JAMA Pediatr. 2024 Jun 1;178(6):525-532. doi: 10.1001/jamapediatrics.2024.0544.
Derived from this study: PubMed 37125831Young LW, Ounpraseuth ST, Merhar SL, Hu Z, Simon AE, Bremer AA, Lee JY, Das A, Crawford MM, Greenberg RG, Smith PB, Poindexter BB, Higgins RD, Walsh MC, Rice W, Paul DA, Maxwell JR, Telang S, Fung CM, Wright T, Reynolds AM, Hahn DW, Ross J, McAllister JM, Crowley M, Shaikh SK, Puopolo KM, Christ L, Brown J, Riccio J, Wong Ramsey K, Akshatha, Braswell EF, Tucker L, McAlmon KR, Dummula K, Weiner J, White JR, Howell MP, Newman S, Snowden JN, Devlin LA; ACT NOW Collaborative. Eat, Sleep, Console Approach or Usual Care for Neonatal Opioid Withdrawal. N Engl J Med. 2023 Jun 22;388(25):2326-2337. doi: 10.1056/NEJMoa2214470. Epub 2023 Apr 30.

Related trials for Neonatal Opiate Withdrawal Syndrome

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Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

26 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time From Birth Until Medically Ready for Discharge (time frame: from date of birth until hospital discharge or 1 year whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04057820, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.