A Trial to Assess Optimal Postoperative Feeding Regiments Following Pyloromyotomy
Condition: Postoperative Feeding Following Pyloromyotomy
Study type: Interventional

Summary: 
      There are several choices to consider when determining the timing of initiation of enteral
      feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as
      the infant awakens from anesthesia. Some authors have suggested a period of withholding
      feedings for several hours postoperatively, while others have recommended a significantly
      longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises
      over whether a physician chooses a standardized, incremental feeding regimen versus an ad
      libitum feeding schedule which allows the infant to decide when and how much to eat. Neither
      has been studied effectively in a randomized controlled setting. A recent review of the
      literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be
      the best postoperative regimen. This however, has not been studied in a randomized,
      controlled trial.
    

Detailed description: 
      A. SUMMARY AND SPECIFIC AIMS B. RESEARCH DESIGN AND METHODS C. REFERENCES

      SUMMARY AND SPECIFIC AIMS

      Infantile hypertrophic pyloric stenosis is a condition well known to pediatric surgeons, and
      has been deemed "the most common cause for surgery in the first 6 months of life". This
      condition affects a large group of children annually with an incidence of 1.8 per 1000
      births. Postoperative length of hospital stay is a financial concern and remains a potential
      target for reduction in hospital costs. Ultimately, these costs are directly affected by the
      ability to effectively advance postoperative enteral nutrition. Some experts calculated this
      savings to be $392.00 per patient while others estimate an impressive $1,290 saved per
      patient.

      There are several choices to consider when determining the timing of initiation of enteral
      feeds following a pyloromyotomy. Some practice patterns have initiated feedings as soon as
      the infant awakens from anesthesia. Some authors have suggested a period of withholding
      feedings for several hours postoperatively, while others have recommended a significantly
      longer period of starvation (18 hours) before initiating feedings. The ongoing debate arises
      over whether a physician chooses a standardized, incremental feeding regimen versus an ad
      libitum feeding schedule which allows the infant to decide when and how much to eat. Neither
      has been studied effectively in a randomized controlled setting. A recent review of the
      literature would suggest that a period of 4 hours of NPO, followed by ad lib feedings may be
      the best postoperative regimen. This however, has not been studied in a randomized,
      controlled trial.

      The investigators therefore hypothesize that 1) infants provided with an ad lib diet
      following pyloromotomy will progress more rapidly to full volume feeds than infants provided
      an incremental advancement in diet, and 2) Preoperative blood chemistry abnormalities will
      predict increased emesis postoperatively.

      Therefore, the specific aims of this study are to determine whether:

        1. Infants who are provided ad lib feeds following pyloromyotomy will progress more quickly
           to goal feeds (100ml/kg/day) and be able to be discharged more rapidly.

        2. Preoperative abnormalities in potassium, chloride, and bicarbonate will predict
           increased postoperative emesis

      B. RESESRCH DESIGN AND METHODS

      B1. Experimental Design.

      Specific Aim 1. Hypothesis: Infants who are provided ad lib feeds following pyloromyotomy
      will progress more quickly to goal feeds (100ml/kg/day) and be able to be discharged more
      rapidly.

      Rationale: If infants are able to reach goal feeds more quickly without experiencing
      significant emesis, then they may be able to be discharged more quickly, thereby decreasing
      hospital costs associated with longer hospital stays

      Experimental protocol:

      Infants will be examined and assessed for a diagnosis of pyloric stenosis. Infants will be
      diagnosed based on standard of care measures (clinical, ultrasound or UGI findings) and will
      have preoperative blood chemistries drawn as per standard of care. At the time surgical
      consent is obtained, the attending or fellow physician will educate the parents about the
      study and obtain consent if they wish to participate.

      The unit of randomization will be the child. Randomization will be done using numbered,
      sealed, security envelopes available to investigators in the pediatric surgery office. Half
      of envelopes will assign the child to the "Standard/Incremental" feeding regimen, and the
      other half will assign the child to the "Ad-lib" regimen. The envelopes will be arranged in a
      box in random order. The investigator will select and open the envelope sequentially after
      each enrollment and informed consent of parents of the children.

      Standard Incremental

        1. NPO for 4 hours following surgery

        2. Initiate Pedialyte at 15ml PO Q2 hours x 2 feeds

        3. Then switch to formula or breastmilk 30ml PO Q2 hours x 2 feeds

        4. Then increase to

             1. 45ml PO Q3 hours x 2 feeds, or

             2. to goal (100ml/kg/day) if goal volume is less than 45 ml

        5. Then advance to goal feeds (100ml/kg/day) PO Q3 hours for 2 feeds

        6. "Time to goal feeds" will be recorded when the infant has tolerated two consecutive goal
           feeds without vomiting and is getting ready to have a third feed

        7. Infants will remain on IV fluids until tolerating goal feeds so as to maintain glycemic
           control and hydration

             -  If vomiting ensues at any stage, repeat same volume of feeding until tolerates 2
                total feedings at that volume and then advance

             -  If infant vomits three of the same volume feeds in a row, skip the next feed and
                restart at same volume thereafter. If vomiting still persists, hold the next two
                feeds and then restart feeds at same volume thereafter

             -  Reglan may not be used during the first 72 hours postoperatively

      Ad-lib

        1. NPO for 4 hours following surgery

        2. Ad-lib formula or breastfeeds until tolerating goal feeds (100ml/kg/day) x 2 total
           feeds. Feedings will be limited to 12.5ml/kg per feed so as to avoid overdistention of
           the stomach

        3. "Time to goal feeds" will be recorded when the infant has tolerated two consecutive goal
           feeds without vomiting and is getting ready to have a third feed

        4. Infants will remain on IV fluids until tolerating goal feeds so as to maintain glycemic
           control and hydration

             -  If infant vomits three feeds in a row, skip the next feed and restart ad lib feeds
                thereafter.

             -  Reglan may not be used during the first 72 hours postoperatively

      Infants will need to tolerate two goal feeds without vomiting prior to being discharged.
      After tolerating two feeds, infants will need to stay in the hospital until it is time for
      the third feed. The initiation of the third feed will be noted as the "time to goal feeds."

      Additional variables to be recorded include age, sex, birth weight, gestational age at birth,
      preoperative weight, preoperative days of vomiting, preoperative resuscitation volume,
      dimensions of pylorus on ultrasound/UGI, preoperative blood chemistries, laparoscopic or open
      procedure, and parental satisfaction of the feeding regimen. Additionally, a phone call will
      be made within 7-14 days following discharge to assess the infants clinical status as well as
      continued parental satisfaction. Parents of infants who do not consent for randomization will
      be asked to allow for perioperative data collection only so that we can get a baseline of our
      entire pyloric stenosis population. The infants whose data will be collected but who are not
      randomized will not have their data included in the randomization analysis

      Specific Aim 2. Hypothesis:. Preoperative abnormalities in potassium, chloride, and
      bicarbonate will predict increased postoperative emesis.

      Rationale: A single previous study has suggested that the degree of preoperative dehydration,
      particularly associated with blood chemistry abnormalities in potassium, chloride, and
      bicarbonate, may predict which infants will have more vomiting postoperatively. If able to be
      identified, these infants may benefit from a tailored feeding regiment postoperatively.

      Experimental protocol: Post hoc analysis will be undertaken to confirm if preoperative blood
      chemistry abnormalities predict postoperative emesis. Also, we will be able to determine if
      an incremental or adlib feeding regiment is best suited for this population of infants as
      well.
    

Intervention name(s): Incremental Feeds; Ad lib feeds
Intervention type(s): Other; Other
Intervention description(s): This arm of patients will be fed in the traditional standard of care manner following pyloromyotomy. They start with 15ml of pedialyte and advance by 15ml increments of formula or breastmilk to a goal of 100ml/kg/day; This arm of patients will be fed ad lib following pyloromyotomy. They will be allowed to eat as frequently as they desire based on infant cues to a goal of 12.5ml/kg/feed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care