Neonatal Abstinence SyndromePhase 2NCT02178189
RCT of High- vs. Standard-Calorie Formula for Methadone-Exposed Infants
A Phase 2 study testing High Calorie Infant formula and Standard Calorie Infant Formula in people with Neonatal Abstinence Syndrome, run by University of Pittsburgh at 1 site in United States.
Trial summary
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- High Calorie Infant formula and Standard Calorie Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born to pregnant women, who are 18 to 45 years of age, participating in a licensed methadone maintenance treatment program
- planning to delivered at Magee if consented during pregnancy or delivered at Magee within the past 48 hours
Who cannot join
- Infants born weighing <2200 grams or before 35 weeks
- Multiple gestation pregnancies (eg. twins)
- Infants with major congenital malformations that could interfere with feeding or weight gain, such as Downs syndrome, cleft lip or palate, congenital heart disease or cystic fibrosis will be excluded.
- Infants admitted to the NICU longer than 48 hours for a medical condition other than treatment of NAS
- Women who do not speak English will be excluded because study staff will not be able to communicate effectively.
- Women who intend to place their infant for adoption
- Women who plan on feeding their baby soy formula from birth
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Randomized Clinical Trial of High vs. Standard-Calorie Formula for Methadone-Exposed Infants
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.
Read the detailed description
Background: Infants exposed to methadone during pregnancy experience high rates of neonatal abstinence syndrome (NAS). Common NAS symptoms (tremulousness, increased muscle tone, sweating, excessive crying, vomiting and diarrhea) increase infants' metabolic needs. Another frequent NAS symptom, weak and uncoordinated suckling, impairs infants' ability to take in adequate calories. These combined problems compromise infant weight gain. The current standard of care for opiate-exposed infants requires evidence of poor weight gain or excessive weight loss before initiating high-calorie formula. We hypothesize that inadequate caloric intake among methadone exposed infants may result in excessive weight loss, slow weight regain and exacerbation of NAS. These factors lead to the newborn's requirement for higher morphine doses and longer duration of hospitalization. Therefore, methadone exposed infants may benefit from early caloric enhancement. A nutritional intervention for opiate-exposed infants has not been previously evaluated. This application will provide data on adequacy of recruitment, protocol feasibility, performance of selected measures, and preliminary estimates of efficacy for a comprehensive R01 submission.
Specific Aims:
- For methadone exposed infants, compare infants randomized to high (24 kcal/oz) versus standard (20 kcal/oz) formula for the following outcomes:
- Weight loss and gain patterns. The primary dependent measure will be days until the infant returns to birth weight. Secondary measures will be maximum percent weight loss and days to weight nadir.
- NAS severity measured by: a) total length of hospital stay for NAS; b) duration of NAS treatment; c) mean Finnegan scores on days 2-10; d) maximum concentration of morphine used to treat NAS.
- Describe the suck quality at 4-6 days of age among methadone exposed infants. Evaluate the association between the infant suck quality and infant weight loss and gain patterns and measures of NAS severity.
Design: Women on methadone will be recruited during pregnancy and will attend a single brief visit late in pregnancy. After delivery, infants will be randomized in a double blind trial of either high-calorie or standard-calorie formula which will be started at 72 hours after birth and be continued through 21 days of age. Infants will be weighed daily and will have outpatient study visits at 1 and 3 months. For this pilot study, up to 70 mothers will be enrolled over 18 months. This pilot study is needed to establish the feasibility of the study methods and to better estimate differences that can be observed between the groups. For the primary outcome variable, days until the infant returns to birth weight, discrete survival methods will be used.
Potential Impact: Early caloric enhancement for methadone-exposed infants is inexpensive, readily available, easy to implement and could improve outcomes of these high-risk infants. High-calorie formula could result in a more normal pattern of weight loss and gain, less severe NAS symptoms and shorter hospital stays.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- High Calorie Infant formula, Standard Calorie Infant Formula
- Keywords
- prenatal opioid exposure, infant, weight gain, infant formula
- Medical subject headings
- Neonatal Abstinence Syndrome, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Calorie Infant formulaOther
Infants were randomized to be fed high calorie formula from 72 hours of life until age 21 days.
Standard Calorie Infant FormulaOther
Infants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Standard-calorie infant formula | Active comparator | Infants assigned to this arm were fed standard-calorie infant formula (20 kcal/oz) from 72 hours of life until 21 days of age. Receives: Other: Standard Calorie Infant Formula |
| High-calorie infant formula | Experimental | Infants assigned to this arm were fed high-calorie infant formula (24 kcal/oz) from 72 hours of life until 21 days of age. Receives: Other: High Calorie Infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Patterns (gain and loss)
Weight loss and gain patterns will include days to return to birth weight, days to weight nadir (lowest point) and maximum percent weight loss.
Measured: Up to 3 weeks
Secondary outcomes (1)
Neonatal abstinence syndrome (NAS) severity measures
NAS (Neonatal abstinence syndrome) severity can be measured in a few ways - for this study, we will use total length of hospital stay for NAS, duration of NAS treatment, mean Finnegan scores on days 3-10 and maximum concentration of morphine used to treat NAS
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2014 (estimated)
- Study startApr 2010
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Abstinence SyndromeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Debra L. Bogen, University of Pittsburgh
- Investigators
- Debra L Bogen, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02178189
- Sponsor's protocol ID
- PRO09120457
- Other IDs
- R21DA029257
- Status last verified
- Jun 2014
- First submitted
- 26 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of High vs. Standard-Calorie Formula for Methadone-Exposed Infants
- ClinicalTrials.gov ID
- NCT02178189
- Acronym / sponsor ID
- PRO09120457
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- prenatal opioid exposure, infant, weight gain, infant formula
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Apr 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neonatal abstinence syndrome (NAS) symptoms contribute to poor infant weight gain. Early caloric enhancement for infants exposed to methadone is inexpensive, readily available, easy to implement and could improve early outcomes for these high-risk infants. We will conduct a preliminary randomized clinical trial of high-calorie vs. standard-calorie formula for methadone exposed infants to evaluate the adequacy of recruitment, protocol feasibility and estimates of whether high-calorie formula results in more normal patterns of weight loss and gain, less severe NAS symptoms and shorter hospital stays.
Detailed description
Background: Infants exposed to methadone during pregnancy experience high rates of neonatal abstinence syndrome (NAS). Common NAS symptoms (tremulousness, increased muscle tone, sweating, excessive crying, vomiting and diarrhea) increase infants' metabolic needs. Another frequent NAS symptom, weak and uncoordinated suckling, impairs infants' ability to take in adequate calories. These combined problems compromise infant weight gain. The current standard of care for opiate-exposed infants requires evidence of poor weight gain or excessive weight loss before initiating high-calorie formula. We hypothesize that inadequate caloric intake among methadone exposed infants may result in excessive weight loss, slow weight regain and exacerbation of NAS. These factors lead to the newborn's requirement for higher morphine doses and longer duration of hospitalization. Therefore, methadone exposed infants may benefit from early caloric enhancement. A nutritional intervention for opiate-exposed infants has not been previously evaluated. This application will provide data on adequacy of recruitment, protocol feasibility, performance of selected measures, and preliminary estimates of efficacy for a comprehensive R01 submission.
Specific Aims:
- For methadone exposed infants, compare infants randomized to high (24 kcal/oz) versus standard (20 kcal/oz) formula for the following outcomes:
- Weight loss and gain patterns. The primary dependent measure will be days until the infant returns to birth weight. Secondary measures will be maximum percent weight loss and days to weight nadir.
- NAS severity measured by: a) total length of hospital stay for NAS; b) duration of NAS treatment; c) mean Finnegan scores on days 2-10; d) maximum concentration of morphine used to treat NAS.
- Describe the suck quality at 4-6 days of age among methadone exposed infants. Evaluate the association between the infant suck quality and infant weight loss and gain patterns and measures of NAS severity.
Design: Women on methadone will be recruited during pregnancy and will attend a single brief visit late in pregnancy. After delivery, infants will be randomized in a double blind trial of either high-calorie or standard-calorie formula which will be started at 72 hours after birth and be continued through 21 days of age. Infants will be weighed daily and will have outpatient study visits at 1 and 3 months. For this pilot study, up to 70 mothers will be enrolled over 18 months. This pilot study is needed to establish the feasibility of the study methods and to better estimate differences that can be observed between the groups. For the primary outcome variable, days until the infant returns to birth weight, discrete survival methods will be used.
Potential Impact: Early caloric enhancement for methadone-exposed infants is inexpensive, readily available, easy to implement and could improve outcomes of these high-risk infants. High-calorie formula could result in a more normal pattern of weight loss and gain, less severe NAS symptoms and shorter hospital stays.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-calorie infant formula | Active comparator | Other: Standard Calorie Infant FormulaInfants assigned to this arm were fed standard-calorie infant formula (20 kcal/oz) from 72 hours of life until 21 days of age. |
| High-calorie infant formula | Experimental | Other: High Calorie Infant formulaInfants assigned to this arm were fed high-calorie infant formula (24 kcal/oz) from 72 hours of life until 21 days of age. |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born to pregnant women, who are 18 to 45 years of age, participating in a licensed methadone maintenance treatment program
- planning to delivered at Magee if consented during pregnancy or delivered at Magee within the past 48 hours
Key exclusion criteria (7 listed)
- Infants born weighing <2200 grams or before 35 weeks
- Multiple gestation pregnancies (eg. twins)
- Infants with major congenital malformations that could interfere with feeding or weight gain, such as Downs syndrome, cleft lip or palate, congenital heart disease or cystic fibrosis will be excluded.
- Infants admitted to the NICU longer than 48 hours for a medical condition other than treatment of NAS
- Women who do not speak English will be excluded because study staff will not be able to communicate effectively.
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 |
|---|---|---|
| High Calorie Infant formulaInfants were randomized to be fed high calorie formula from 72 hours of life until age 21 days. | Other | High-calorie infant formula |
| Standard Calorie Infant FormulaInfants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days. | Other | Standard-calorie infant formula |
Primary outcome
Weight Patterns (gain and loss)
Time frame: Up to 3 weeks
Weight loss and gain patterns will include days to return to birth weight, days to weight nadir (lowest point) and maximum percent weight loss.
1 secondary outcome
Neonatal abstinence syndrome (NAS) severity measures
Time frame: Up to 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
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Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
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An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
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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.
Debra L Bogen, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High Calorie Infant formula and Standard Calorie Infant Formula in people with Neonatal Abstinence Syndrome, run by University of Pittsburgh at 1 site in United States.
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 2 inclusion and 7 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 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight Patterns (gain and loss) (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2014.