this material is based on work supported by nih under
TRANSCRIPT
This material is based on work supported by NIH under Prime Award no. UL1 RR031985 and The Regents of the University of California.
NICU Control
Submit Proposal to IRB
Recruitment Started Feb 2012
30 Mothers of infants EGA of 31-36 who initiated breastfeeding but have not been discharged and
are <8 days old
Data Collection: Mothers followed via phone calls for 6 months from infant's birth for these outcomes: 1. Milk Supply at Discharge 2. Breastfeeding Exclusivity and Duration to Weaning or a Maximum of 6 months 3. Survey of Breastfeeding Problems and Outcomes4. Data Collection Ended 11/2012
n=27 Dyads n=31 Infants
NICU CASE
Order Supplies and Set up Clinic
Began July 2012 Recruit 30 Mothers of infants EGA 31-36 who
are less than 8 days old
Contact Mothers weekly until Discharge
At Discharge, given an outpatient follow up appointment within 7 days
Follow dyads bi-weekly or weekly to manage breastfeeding, milk supply, infant growth and other problems. Most
Problems are resolved by the 3rd month
Data Collection: Mothers followed via phone calls for 6 months from infant's birth for these outcomes:
1. Milk supply at Discharge 2. Breastfeeding Exclusivity and Duration to Weaning for a maximum of 6 months 3. Survey of Breastfeeding Problems and Outcomes
Completed 11/2013
n=24 Dyads n=28 Infants
*Exclusive: producing 100% of infant’s food or feeding only human milk without the addition of other fluids or solids with the exception of those that are medically prescribed. This does not mean that an infant was NEVER fed anything but human milk.
**Weaned: no longer receiving human milk via breast or supplementation for 1 week. Thus infants could be breastfed as little as once a week and still be counted as breastfed for durations rates.
***Month: expressing or feeding maternal milk at least 21 days. It was considered exclusive if for 21 days the mother either: expressed >480cc/child or the infant was fed 100% human milk.
****Colostrum Care: NPO infants were considered to be exclusively fed 100% human milk
100%
For
mul
a
100%
Bre
astfe
edin
g
Exc
lusive
BF
G
rou
p
Pre
do
min
an
t
BF
Gro
up
50
% B
F G
rou
p
Min
ima
l BF
G
rou
p
Formula
Group vs
50%
Comparison of the Control and Case Groups
Values Control Case P Values (Fisher’s Exact)
N= 27 mothers* 31 infants*
24 mothers 28 infants
N/A
Lost to Follow-Up 18.5% (5/27) 3 Declined/Not Qualified 1 Fetal Demise
8.0% (2/24) 10+ Declined/Not Qualified
.42
# Completed Program 25/27 (2 mo) 23/27 (3 mo) 22/27 (6 mo)
23/24 (4mo) 22/24 (6 mo)
N/A
Gender % 52% (15/29) Girls 38% (14/29) Boy
39% (11/28) Girls 52 % (17/28) Boys
.43
NVSD Delivery % 50% (12/24) 62.5% (15/24) .56
Birth # Single=23 Twins=4 Single=20 Twins=4 NS
Gravity/Parity Range G= 1-10 P= 1-9 G= 1-5 P= 1-4 N/A
*Data Not Available for 3 in Control and in 1 case mother data was missing for pre-partum weight
*Data Not Available for 3 in Control and in 1 case mother data was missing for pre-partum weight
Comparison of Mean Values for the Control and Treatment Groups
Means Control* Case* P values (T-test)
EGA (Weeks) 33.8 33.6 .63 BW (Grams) 2216.5 2179.8 .74 Maternal Age (Years) 28.9 28.5 .85 Pre-pregnancy Maternal Weight (Lbs.)
155.1 147.9 .58
Gravity 2.7 2.2 .38 Parity 2.3 2.0 .58
Unexpected Subgroup Milk Supply Exclusivity Rates Durations Rates Goals and Mean Durations Qualitative Data
Comparison of the Case SUBGROUPS
Values Seen Cases Unseen Cases P Value N= 11 mothers
12 infants 13 mothers 16 infants
N/A
Lost to Follow-Up 1/11 1/13 NS
Gender % 33 % (4/12) Girls 67 % (8/12) Boy
44% (7/15) Girls 56% (9/15) Boys
.71
NVSD Delivery % 45% (5/11) 80% (10/13) .21
Birth # Single=10 Twins=1
Single=12 Twins=3 NS
Gravity/Parity Range G= 1-5 P=1-4 G= 1-3 P= 1-3 N/A
Comparison of Mean Values for the Control and Treatment Groups Means Seen
Cases Unseen Cases
P values (T-test)
EGA (Weeks) 33.4 33.8 .32 BW (Grams) 2122.1 2223.1 .30 Maternal Age (Years) 31.2 24.5 .14 Pre-pregnancy Maternal Weight (Lbs.) 122.6 157.8 .22 Gravity 2.6 1.9 .17
Parity 1.6 1.9 .54
Milk Supply Estimates
Volumes Recorded by LC or Reported by Mother closest to Discharge
Breastfeeds Were Estimated at 10cc/feed
Discrepancies Were Handled by Using Means
Methods
0.73
0.27 0.30
0.70
0%10%20%30%40%50%60%70%80%
>480 <480
SeenCasesUnseenControl
Percent and Odds of >480cc at Discharge
Odds Ratio's for >480cc >480 OR CI RR CI
Cases vs Control 3.33 1.05—10.59 1.98 1.05—3.86 Control vs Unseen 2.04 0.52—8.00 1.56 0.68—3.56
Seen vs Control 6.33 6.33—30.23 2.46 1.24—4.87
Unseen vs Seen 3.11 .56—17.33 1.58 0. 80—3.14
Mean Milliliters per Mother and Child
696.40 638.30
597.70
512.40 514.20
417.80 359.40
313.10
0.00
100.00
200.00
300.00
400.00
500.00
600.00
700.00
800.00
Mean/Mother Mean/Child
SeenCaseUnseenControl
0.028
0.0016
0.0026
0.050
0.017 0.039
0.001
0.050
>480cc ml/Mother ml/child
P values for Milk Supply
Control vsSeen
Control vsCase
Seen vsUnseen
Milk Supply Differences Statistically Significant for Control vs Case and Seen
Vohr et al. PEDIATRICS Volume 120, Number 4, October 2007 at: www.pediatrics.org/cgi/doi/10.1542/peds.2006-3227
Milliliter/Kg Outcomes Based Upon a Study of VLBW (<1000grms)
0.0%
20.0%
40.0%
60.0%
80.0%
Rehospitlization OR
Seen
Case
Unseen
Control
Exclusivity Control vs Case
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
1m 2m 3m 4m 5m 6m
Case Exclusivity
Control Exclusivity
Exclusivity: Group and Subgroup Comparison
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
1m 2m 3m 4m 5m 6m
Seen
Case
Control
Unseen
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
1m 2m 3m 4m 5m 6m
Case>400
Control>400
Both>400
Case<400
Control<400
Both<400
Month RR CI OR CI
1 3.40 1.74—6.63 17.00 3.81—-75.88
2 1.46 1.04—2.06 NS
3 1.40 1.00—-1.96 NS
4 1.35 1.08—-1.69 NS
5 1.29 1.05—-1.57 NS
Relative Risk and Odds Ratio of Weaning and/or Non-Exclusive Breastfeeding 1-5 Months Based on Milk Supply < or > 400cc’s
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
1m 2m 3m 4m 5m 6m
SeenBoth>400CaseControlUnseenBoth<400
Durations for Supply > or <400cc @ Discharge Group Comparisons
0.0%
20.0%
40.0%
60.0%
80.0%
100.0%
120.0%
1 2 3 4 5 6
Control>400
Case>400
Both>400
Case<400
Control<400
Both<400
Relative Risk and Odds Ratio of Weaning from 2-6 Months Based on Milk Supply < or > 400cc’s
Month RR CI OR CI
2 3.63 1.08—12.25 5.30 1.15—-24.40
3 4.37 1.60—11.52 10.54 2.46—-45.16
4 3.60 1.70—-7.62 14.00 2.95—-66.41
5 2.80 1.62—-4.85 28.00 3.16—247.91
6 2.43 1.47—-4.02 22.40 2.54—197.60
Percent >400cc by Group
0%10%20%30%40%50%60%70%80%90%
>400 <400
Seen
Cases
Unseen
Control
Odds Ratio's for >400cc By Group >400 OR CI RR CI:
Cases vs Control 2.50 0.80—7.81 1.50 0.90—2.49
Control vs Unseen 1.46 0.39—5.5 1.21 0.63—2.34
Seen Cases vs Control 5.63 1.01—31.1 1.84 1.11—3.05
Unseen Cases vs Seen 3.86 0.59—26.29 1.52 0.85—2.71
Exclusivity Goal Measurements Asked if they wanted to breastfeed
exclusively-Yes or No
Duration Goals Measurements
Means were Used if A Range was Entered Not Sure was Entered as “0”
Methods
P Values Control vs Case
Control vs Seen
Cases vs Seen
Seen vs Unseen
Goals (Fisher’s Exact) .58 .17 .47 .22
Exclusivity Mean Rates (T-test) .39 .10 .37 .17
2.18
1.50
1.04 0.92
0.00
0.50
1.00
1.50
2.00
2.50
Mean Duration
Cases SeenCasesControlCases Unseen36%
54.20% 63%
69.30%
0%
10%
20%
30%
40%
50%
60%
70%
80%
Exclusive Breastfeeding Goals
SeenCaseControlUseen
0
1
2
3
4
5
6
7
8
9
10
Prenatal MeanDuration Goals
Censored MeanPrenatal Duration
Goals
Total Actual MeanDuration
Cases Seen
Cases
Control
CasesUnseen
Comparison of Groups For Goals vs Durations
* n=25 for censored goals because 2 were excluded for either no answer or for an ambiguous answer.
Mean Goals and Durations By Group
Control Cases Cases
Seen Cases Unseen
Participants n= 25* 24 11 13 Prenatal Mean Duration Goals** 7.86 mo 8.95 mo 9.00 mo 8.90 mo Censored*** Mean Prenatal Duration Goals 4.74 mo 5.79 mo 4.90 mo 5.20 mo Total Actual Mean Duration 3.07 mo 3.58 mo 4.82 mo 2.54 mo
Difference 1.67 mo 2.21 mo 0.08 mo 2.66 mo
P VALUES (Goals vs Means) 0.003* 0.004 0.90 0.0002
*2 were excluded for no answer or an ambiguous answer **When mothers gave a range of months, mean value was used and they were unsure a score of “0” months was used ***Used Maximum Duration Goal of 6 months for those with longer goals because data only collected to 6 months
Significant Differences for Mean Duration Between Groups
Group Comparisons Control vs Case
Control vs Seen
Cases vs Seen
Seen vs Unseen
P value (T-test) 0.41 0.016 0.11 0.008
Qualitative Data
Mismanagement and Barriers
Type and Number of Problems
LMS, Latch and Resolution
Treatment
Inadequate Pumping Equipment
Flange Too Small
Tongue-Ties
Provider Knowledge Deficits
Control 14.8%
.037% (n=1/27) 0% reported 14.8% (n=3/27)
1/27 WIC Repossessed 1/27 D/C w/out Electric 2/27 With expression problem
1/27 Advised LMS untreatable after 4-6 wks 2/27 Advised weaning for safe med
Case 58.3% 33.3% (n=8/24) 11% (n=2/18)*
41.6% (n=10/24) 16.7% (4/24) Weaned 16.7% (4/24) Non-exclusive)
4/24 No Pump Coverage 3/24 D/C w/out Electric 3/24 Mechanical problems
Flange and Pump Problems Likely Underreported in Control
Likely Underreported Especially in Control
1/21 Advised to wean for safe med 1/21 Weight mismanagement 1/21 Uundx ductal infection 1/21 Untx nipple retraction 1/21 Inappropriate supplementation 1/21 Misdx milk allergy 2/24 Advised solids for reflux 2/24 Untreated Tongue-Tie
*5 Dyads never examined
100.0% 88.9% 87.5% 76.9%
75.0% 58.1% 50.0%
26.7%
63.6%
25.9% 45.8%
23.1%
81.8%
14.8%
58.3%
38.5%
0
1
2
3
4
Seen Cases Control Cases UnseenCases
Tongue-TiePWGColic/RefluxPumpPainLatchLMS
% Other Problems Reported
Assorted Maternal Problems
Assorted Infant Problems
Control 16.1% Colic or Reflux 9.7 % Sleepy, Fatigued or Low Tone 9.7% Poor Weight Gain 9.7% Oversupply/Overactive letdown At least 1 with transportation problems
1 infant Medication Problem 2 Little Time or Stressed 1 Mother Hospitalized 1 Renal Failure 1 Renal Calculi 1 Accident Caused Loss of Milk
1 Nipple Confusion Twin Infants Hospitalized (RSV) 2 Constipation 2 Thrush 1 Bronchitis1 Aspiration 1 Gut Issues 1 Gastroschisis
Case 14.2% Sleepy Baby 10.7% Poor Weight Gain 10.7% Colic or Reflux At least 33% (8/24) with transportation problems
2 Retracting/Flat Nipple 1 Oversupply 2 with Depression 1 Renal Failure 1 Lupus 1 Gastric Bypass
2 Sleepy/Tired Baby 1 ER visit for Respiratory Distress 1 Multiple Problems/Surgeries 1 Inguinal Hernia Repair 1 Gastroschisis
•5 dyads never examined
•13/24 did not attend an appt.
0%10%20%30%40%50%60%70%80%90%
100%110%
Total Resolved Improved Total Resolved
Low Milk Supply Latch
SeenCaseUnseenControl
Latch
P values Resolved
Case vs Control 0.7300
Case vs Seen 0.1760
Control vs Seen 0.0875
Seen vs Unseen 0.0070
Case vs Unseen 0.0915
* 2 Excluded
0%10%20%30%40%50%60%70%80%90%
100%110%
Total Resolved Improved Total Resolved
Low Milk Supply Latch
SeenCaseUnseenControl
Low Milk Supply
P values Resolved Improved Either Case vs Control* 0.0389 0.0192 0.0001
Case vs Seen 0.7026 0.4719 0.1378
Control* vs Seen 0.0260 0.0039 0.0001
Seen vs Unseen 0.3108 0.3940 0.0124
Case vs Unseen 0.3800 1.0000 0.2200
* 2 Excluded
o CONTROL ◦ 12 had LMS at D/C (2 had LMS for Twins but >16 oz) ◦ 3 Developed LMS after D/C ◦ 5 Mothers reported using galactogogues 1 Reglan (metaclopramide) 3 Fenugreek 1 Cultural Remedy
o CASE 14 LMS in-hospital 7 LMS Post-Discharge 10 (41%) Mothers treated with Reglan (metaclopramide)
8 responded (1 Unknown and 1 didn’t respond but had undx ductal infection)
6 treated with fenugreek (Some took both)
Summary Group Differences ◦ ALL NS
Except Insurances: ◦ Control-Assorted HMP,
PPO and Medi-Cal
◦ Case-Medi-Cal with 2 PPO and 1 Healthy Families
Significant Findings Milk Supply @ Discharge ◦ >480cc ◦ ml per mother and child
Breastfeeding Rates ◦ Goals vs Durations ◦ Exclusivity (Clinically) ◦ Mean Durations
Problem Resolution ◦ LMS ◦ Latch
What We Learned
1. Having a Breastfeeding Medicine Provider Readily Available to Hospitalized Dyads: • Improves Milk Supply @ Discharge
2. Mothers Who are Discharged with >400cc have a:
• Lower Risk of Early Weaning and are More Likely to Exclusively Breastfeed
3. Maternal Barriers to Success Include:
• Lack of Transportation and Reliable Communication • Pump Availability and/or Problems with Pumping • Medical Mismanagement Leading to Weaning and Non-Exclusive Breastfeeding
4. Case Mothers (SEEN) that Followed Up with a BFM Provider After Discharge Were
More Likely to Have: • Met Their Breastfeeding Goals • Higher Mean Breastfeeding Durations • Breastfed Exclusively Longer (Clinically Significant) • Improved or Resolved LMS • Reported Resolution of Latch Problems Than Those Unseen
1. Provide Specialized Lactation care via Home Care or at all Well Baby Visits via: A) A Lactation Consultant working alongside the PCP’s B) Teaching Pediatric Health Care providers to manage breastfeeding or dyads C) Have Breastfeeding Medicine Specialists provide care to all breastfed infants.
2. Adapt the “Baby-Friendly” criteria for the NICU and explore:
A) The use of a “Breast-first and Bottle-Free or Last” NICU Protocol B) Ad lib breastfeeding once 50% of a feeding can be transferred from the breast C) The effects of maternal rooming-in 48 hours prior to D/C D) Providing transportation
E) Training Providers in the identification and treatment of tongue-tie
3. Lower Loss to Follow-Up and Improve Access and Compliance by: A) Providing cell phones B) Offering Incentives i.e. reward mothers with their own double-electric pump if Still Pumping at Discharge and/or They Follow Up. C) Provide Transportation to Hospital and/or Appointments
5. Consider using 400 cc’s at D/C as the critical ”Breastfeeding Success” value instead of 480 cc’s. 6. Decide upon how to manage the data from the subgroup of dyads that were never examined and/or did not follow up.
Future Research Suggestions