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

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a

100%

Bre

astfe

edin

g

Exc

lusive

BF

G

rou

p

Pre

do

min

an

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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 >480cc Mean milliliters per Mother or Child Mean Milliliters/kg

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

300.8

235.15

188.28

141.29

0

50

100

150

200

250

300

350

ml/kg

SeenCaseUnseenControl

Increased ml/kg

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

0.02.04.06.08.0

10.012.014.016.018.0

>10ml/kg MDI PDI BehaviorScore

Seen

Case

Unseen

Control

Breastfeeding Rates

Exclusivity Duration

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

Breastfeeding Duration Rates

Rates of Weaning

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1m 2m 3m 4m 5m 6m

Case DurationsControl Durations

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

Goals

Group Mean Comparisons Comparisons to Mean Durations

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

0

0.5

1

1.5

2

2.5

3

3.5

4

Unseen Cases

Cases

Control

Seen Cases

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

Questions? Comments NICU COUNTYWIDE COLLABORATION