Role of Low Lactose Infant Formula In The Management of Neonatal Abstinence Syndrome
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Study type: Interventional

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. 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.
    

Intervention name(s): Low lactose or regular formula
Intervention type(s): Other
Intervention description(s): 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".
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double Blind Clinical trial on Role of Low Lactose Formula In the Management of Neonatal Abstinence Syndrome
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: NAS, low lactose formula