Neonatal Abstinence SyndromeNCT03549936
Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
A study testing Low lactose or regular formula in people with Neonatal Abstinence Syndrome, run by MetroHealth Medical Center at 1 site in United States.
Trial summary
Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. Read more about this study
- Who is it for?
- Ages 1 minute to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Neonatal Abstinence Syndrome
- What is being tested?
- Low lactose or regular formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jul 2014to 30 Jun 2018
- Phase
- Interventional
- 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 minute to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Intrauterine exposure of opiate and related drugs-morphine
- Late preterm or full term (36-42 weeks of gestation)
Who cannot join
- Major congenital anomalies
- Post-surgical cases
- Major respiratory, cardiovascular, neurological or metabolic disorders
- Less than 36 completed weeks of gestation
Trial locations and contacts
1 site in 1 country.
About this study
Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS.
This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.
Read the detailed description
At birth, and after written informed consent, investigators will encourage opiate dependent mothers to breast feed if appropriate in accordance with hospital NAS management guidelines (sober for at least 4-6 months, enrolled in a drug treatment program, HIV negative). If mother is unable to breast feed and or chooses formula feeding for the infant or the infant needs supplemental formula due to inadequate lactation or poor weight gain, then the infant will be randomized to either receive blinded "low lactose formula Similac Sensitive" or "regular cow mild based formula Similac Advance". These will be simply labelled as Formula A and formula B. The randomization will be done using computer generated random number coupled with stratified balanced blocked methodology. Recent reformulations by Abbott Nutrition in the US market nation wide has resulted in "low lactose formula Similac Sensitive" being made 19 cal/oz or 20 cal/oz or "regular cow mild based formula Similac Advance" which is now only available as 19 cal/oz instead of 20 cal/oz. This change in calorie density has occured to reflect newer data suggested that human breast milk has 19 cal/oz instead of 20 cal/oz as believed previously. Abbott has continued to make 20 cal/oz Similac sensitive because many many providers across the country are using this for NAS babies. There are some differences in other carbohydrates other than lactose (both have <1% lactose) in the two Similac Sensitive 19 and 20 cal/oz. The calorie difference is of no clinical significance in term infants because they modulate their volume of milk consumed.
After recruitment and randomization at birth, infants will be fed every 2-3 hrs or on demand and will also be observed for NAS score every 2-3 hours starting soon after birth. Infants will receive their "medical provider directed" standard pharmacological and non-pharmacological treatment.
Those who do not demonstrate NAS, will be discharged after 5-7 days of observation. Study formula will be discontinued or may be continued if they or their provider chose to do so.
Infants who develop NAS will continue to receive blinded formula as part of non-pharmacological treatment and will also receive pharmacological treatment (morphine/methadone) as per hospital guidelines directed by their medical care providers. Pharmacological treatment will be optimized and weaned as per standard hospital guidelines. Use of blinded formula A or B will be continued until 2 weeks of age at which point its use as study intervention will be completed. After this point, parents and medical care providers may use formula of their preference. However investigators will offer a choice of continuing the blinded formula until the infant is discharged at which point standard formula will have to be initiated. General clinical data will be collected at discharge including length of stay and weight.
- Conditions
- Neonatal Abstinence Syndrome
- Being tested
- Low lactose or regular formula
- Keywords
- NAS, low lactose formula
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low lactose or regular formulaOther
If infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "low lactose formula" or "regular formula" which arrives from milk lab blinded and labeled as formula "A" or formula "B".
| Study group | Role | What they receive |
|---|---|---|
| Low lactose formula | Active comparator | If infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "low lactose formula" which arrives from milk lab labeled as formula "A" or formula "B". Receives: Other: Low lactose or regular formula |
| Regular formula | Active comparator | If infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "regular formula" which arrives from milk lab labeled as formula "A" or formula "B" Receives: Other: Low lactose or regular formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dose of morphine required to treat NAS.
Every dose of morphine required to treat NAS over first 14 days of life will be noted and total cumulative dose administered will be observed. We expect infants on low lactose formula versus regular formula will require lower cumulative dose of morphine during first 2 weeks of life.
Measured: 14 days of age
Highest dose of morphine required to treat NAS.
Every dose of morphine required to treat NAS over first 14 days of life will be noted. We expect infants on low lactose formula versus regular formula will require lower maximal dose of morphine.
Measured: 14 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2018
- Study start9 Jul 2014
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blind Clinical trial on Role of Low Lactose Formula In the Management of Neonatal Abstinence Syndrome
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Deepak Kumar, MetroHealth Medical Center
- Investigators
- Deepak Kumar, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03549936
- Sponsor's protocol ID
- IRB14-00005
- Status last verified
- Dec 2018
- First submitted
- 6 May 2017
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
PubMed 33348423
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
- ClinicalTrials.gov ID
- NCT03549936
- Acronym / sponsor ID
- IRB14-00005
- Conditions
- Neonatal Abstinence Syndrome
- Keywords
- NAS, low lactose formula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 8 Jun 2018 (actual)
- 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.
Currently Morphine and or Methadone are the most commonly used drugs in the treatment for NAS along with supportive care. Many care providers offer tolerance "low lactose" formula to these infants to alleviate gastrointestinal symptoms. There are no clinical studies to support this practice and it is currently unknown that low lactose formula really helps or not in management of NAS.
This is a Randomized Double Blind Clinical Trial to assess the role of low lactose formula versus standard (regular) formula in managing NAS.
Detailed description
At birth, and after written informed consent, investigators will encourage opiate dependent mothers to breast feed if appropriate in accordance with hospital NAS management guidelines (sober for at least 4-6 months, enrolled in a drug treatment program, HIV negative). If mother is unable to breast feed and or chooses formula feeding for the infant or the infant needs supplemental formula due to inadequate lactation or poor weight gain, then the infant will be randomized to either receive blinded "low lactose formula Similac Sensitive" or "regular cow mild based formula Similac Advance". These will be simply labelled as Formula A and formula B. The randomization will be done using computer generated random number coupled with stratified balanced blocked methodology. Recent reformulations by Abbott Nutrition in the US market nation wide has resulted in "low lactose formula Similac Sensitive" being made 19 cal/oz or 20 cal/oz or "regular cow mild based formula Similac Advance" which is now only available as 19 cal/oz instead of 20 cal/oz. This change in calorie density has occured to reflect newer data suggested that human breast milk has 19 cal/oz instead of 20 cal/oz as believed previously. Abbott has continued to make 20 cal/oz Similac sensitive because many many providers across the country are using this for NAS babies. There are some differences in other carbohydrates other than lactose (both have <1% lactose) in the two Similac Sensitive 19 and 20 cal/oz. The calorie difference is of no clinical significance in term infants because they modulate their volume of milk consumed.
After recruitment and randomization at birth, infants will be fed every 2-3 hrs or on demand and will also be observed for NAS score every 2-3 hours starting soon after birth. Infants will receive their "medical provider directed" standard pharmacological and non-pharmacological treatment.
Those who do not demonstrate NAS, will be discharged after 5-7 days of observation. Study formula will be discontinued or may be continued if they or their provider chose to do so.
Infants who develop NAS will continue to receive blinded formula as part of non-pharmacological treatment and will also receive pharmacological treatment (morphine/methadone) as per hospital guidelines directed by their medical care providers. Pharmacological treatment will be optimized and weaned as per standard hospital guidelines. Use of blinded formula A or B will be continued until 2 weeks of age at which point its use as study intervention will be completed. After this point, parents and medical care providers may use formula of their preference. However investigators will offer a choice of continuing the blinded formula until the infant is discharged at which point standard formula will have to be initiated. General clinical data will be collected at discharge including length of stay and weight.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double Blind Clinical trial on Role of Low Lactose Formula In the Management of Neonatal Abstinence Syndrome
| Arm | Type | Receives |
|---|---|---|
| Low lactose formula | Active comparator | Other: Low lactose or regular formulaIf infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "low lactose formula" which arrives from milk lab labeled as formula "A" or formula "B". |
| Regular formula | Active comparator | Other: Low lactose or regular formulaIf infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "regular formula" which arrives from milk lab labeled as formula "A" or formula "B" |
Who may qualify
- Ages
- 1 minute to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Intrauterine exposure of opiate and related drugs-morphine
- Late preterm or full term (36-42 weeks of gestation)
Key exclusion criteria (4 listed)
- Major congenital anomalies
- Post-surgical cases
- Major respiratory, cardiovascular, neurological or metabolic disorders
- Less than 36 completed weeks of gestation
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 |
|---|---|---|
| Low lactose or regular formulaIf infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive "low lactose formula" or "regular formula" which arrives from milk lab blinded and labeled as formula "A" or formula "B". | Other | Low lactose formula, Regular formula |
Primary outcome
Cumulative dose of morphine required to treat NAS.
Time frame: 14 days of age
Every dose of morphine required to treat NAS over first 14 days of life will be noted and total cumulative dose administered will be observed. We expect infants on low lactose formula versus regular formula will require lower cumulative dose of morphine during first 2 weeks of life.
Highest dose of morphine required to treat NAS.
Time frame: 14 days of age
Every dose of morphine required to treat NAS over first 14 days of life will be noted. We expect infants on low lactose formula versus regular formula will require lower maximal dose of morphine.
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 4 Dec 2018.
- Derived from this study: PubMed 33348423Pahl A, Young L, Buus-Frank ME, Marcellus L, Soll R. Non-pharmacological care for opioid withdrawal in newborns. Cochrane Database Syst Rev. 2020 Dec 21;12(12):CD013217. doi: 10.1002/14651858.CD013217.pub2.
- Individual participant dataSharing planned: No
Related trials for Neonatal Abstinence Syndrome
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Neonatal Abstinence Syndrome, Opioid-use Disorder
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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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Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
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Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
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.
Deepak Kumar, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low lactose or regular formula in people with Neonatal Abstinence Syndrome, run by MetroHealth Medical Center 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 4 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 4 Dec 2018. 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.
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?
Cumulative dose of morphine required to treat NAS. (time frame: 14 days of age). The study lists 2 primary outcomes in all. 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 NCT03549936, which also lists 1 linked publication.
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 4 Dec 2018.