FINAL compromise feeding protocol:
Day of
Type of feed
Birth Weight: Birth Weight:
Birth Weight:
Feeding
401 – 700 gm 701 – 1000 gm 1001 – 1250 gm
ml/kg/day
ml/kg/day
ml/kg/day
1
EHM
15
15
15
2
EHM
15
15
15
3
EHM
15
15
30
4
EHM
15
30
45
5
EHM
15
45
60
6
EHM
30
60
80
7
EHM
45
80
100
8
EHM
60
100
120#
9
EHM
120*
80
120#
10
EHM
120*
140
100
11
EHM
140
160
120#
12
EHM
120*
160
160
13
EHM
140
160
14
EHM
160
15
EHM
160
EHM = expressed human milk or preterm formula 20 kcal/oz
# Primary outcome achieved on the day baby takes 120 ml/kg/d
* Human Milk Fortifier or Preterm Formula 22 kcal/oz initiated
1.
Prior to the study, infants would be started on feedings and advanced according to
individual center preferences.
2.
During the study drug administration period (from first dose of study drug to 24 hours
after last dose of study drug), infants that are randomized to the “feed through study drug
administration period group” will receive a volume of 15 ml/kg/d
3.
After study administration period, infants would be switched to the “study protocol
feeding advance schedule” (which would be started immediately after the study drug
administration period)
4.
When to start the “feeding advance protocol”: We would like infants to start the “study
protocol feeding advance schedule” immediately following the study administration period (the
interval from the first dose of study drug to 24 hours after last dose of study drug). Therefore,
ideally the feeding advance protocol should start 24 hr after the last dose of study drug. This may
be inconvenient if the 24h point falls between 9pm and 5am, since many centers may not want to
start new or increased feedings during the middle of the night. Therefore if the calculated start
time for the first feeding of the “feeding advance protocol” falls between 9pm and 5am, we
would permit the first feeding of the “feeding advance protocol” to occur as early as 16h after the
last dose of study drug, or it could be delayed until the morning when normal feeding orders are
usually written.
5.
To determine feeding amounts, birth weight will be used for the first 7 days of life, after
which feeds should be adjusted for daily weight.
6.
The total volume of feeding per day is set by the protocol. On the other hand, the number
of feedings per day will be at the discretion of each study center. Typical recommended feeding
version (10/20/08)
intervals are q 3 hour or q 4 hour for feeding volumes of 15 ml/kg/d, and q 2 hour or q 3 hour for
feeding volumes ≥30 ml/kg/d.
7.
For bolus feeds, round amount of weight based feeds to the nearest 0.5 ml for feeds ≤ 2.5
ml and to the nearest ml for feeds ≥ 2.6 ml.
8.
When to advance to the next day on the “feeding advance protocol”: An infant’s feeding
volume will be advanced each day according to the “feeding advance protocol”. In many centers,
feeding orders are discussed and written once a day, on morning rounds. In order to advance to
the volume designated for the next “Day of Feeding” on the feeding advance protocol, the infant
would need to have received at least 61% of the previous day’s planned feeding volume before
the change could be made. For example, an infant who weighed 1300 gm at birth and currently
weighs 1200 gm and is currently on day 2 of the “feeding advance protocol” is scheduled to
receive 15 ml/kg/d =18 ml/day. If the infant had only been given 10ml of the planned 18 ml that
he was supposed to receive at the time feeding orders are being written (either because it had
been made NPO for a while or because the feedings had been delayed in starting the day before),
then either the change to the new feeding volume (for day 3 of the protocol it would be 30
ml/kg/d) would not be made until later in the day (when at least 11ml would have been taken at
the current feeding rate) or the change would not be made until the next morning if daily feeding
orders can only be written once a day in that nursery
9.
For babies who never previously fed, who are randomized to the feeding group: the 15
ml/kg/day feedings during the study drug administration period would be counted as part of their
feeding protocol advance
10.
For babies who never previously fed, who are randomized to the non-feeding group, we
would not start the first 15 ml/kg/day feeding until 24 hours after the last dose of study drug.
11.
For study infants who have already been on a feeding advance prior to their entry into the
study: please match the maximum daily volume of feeds (and the number of days that the infant
has been on that volume, either prior to or during the study drug administration period) with the
equivalent number of days on the study protocol feeding advance schedule and then continue
to advance feedings according to the study protocol feeding advance schedule.
12.
Total fluid intake will be at the discretion of the clinician and the partition between
enteral and parenteral nutrition will be calculated daily.
13.
Recommendations for feeding advance AFTER reaching 120 ml/kg/day.The infant is
considered to achieve full enteral feeding when the volume reaches 120 ml/kg/day (of 20 cal/oz
feed). Parenteral nutrition should be discontinued when the infant achieves full feedings of 120
ml/kg/day.
14.
Recommendations for feeding advance AFTER reaching 120 ml/kg/day. Calorie
fortification to 22 kcal/oz should occur when the baby is tolerating 120 ml/kg/day. The feed
advance may be held on the day of calorie fortification so two changes are not implemented on
the same day.
version (10/20/08)
Criteria for Feeding Intolerance and Management of Feeding Regimen.
Signs of feeding intolerance
Management***
Record as
Episode of
Gastric aspirate prior to
Other signs
Feed
the feeding
of feeding
Intolerance
intolerance*
1a*. if both ≤2 ml and ≤1/3
None
Refeed aspirate as part of total
No
of previous feed volume
volume, continue feeding
1b*. if ≤2 ml but >1/3 of
None
Check infant, then may refeed
No
previous feed volume
aspirate as part of total volume,
and continue feeding.
Or may hold feeding and
resume in 3 hours.
2. if >2 ml and > 1/3 of
None
Stop feeding and recheck
Yes
previous feed volume
gastric aspirate in 3 hours.
Resume feeding when
conditions revert to 1 above.
3. Irrespective
Present
Stop feeding, perform appropriate
Yes
evaluation and resume when
infant stable and conditions
revert to 1 above.
*: if continuous naso or orogastric feedings are used, check for residuals q3 – 4 hours.
Tolerate benign-appearing residuals of ≤ 2cc or < 2 hours worth of feeds (whichever is
more.)
** Evaluation of significant feeding intolerance should be performed by the primary
clinical team according to the standard procedure at your institution: (Physical exam,
KUB, CBC, culture, etc).
Other signs will include one or more of the following:
a) dark bile or blood stained gastric aspirate ≥1 ml;
b) vomiting ≥ 1/3 of the previous feed volume;
c) abdominal distension, discoloration or tenderness;
d) visible bowel loops
e) bloody stool;
f) KUB showing signs of intestinal dilatation;
g) metabolic acidosis or new thrombocytopenia;
h) Evidence that the child is not well: apnea (new onset or increasing frequency),
respiratory distress, lethargy, poor perfusion, temperature instability, etc.
***Recommendations: check feeding tube placement; position infant prone, right side
down; consider glycerin suppository if no stools in 18-24 hrs; if recurrent episodes
occur after a recent feed advance or fortification, consider returning to the previously
tolerated feeding volume or concentration
version (10/20/08)