UCI BABIEM RESEARCH PROJECT Christine Betzold NP IBCLC MSN Other Team Study Members: Robin Koeppel MS, CPNP, CNS Mallory Harris BSN, RN, IBCLC Virginia Bernal RN, IBCLC This material is based on work supported by NIH under Prime Award no. UL1 RR031985 and The Regents of the University of California.

Recruitment Started Feb 2012 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 End By 4/30/2012 Data Collection: Mothers followed via phone calls for 3 months from infant's birth for these outcomes: 1. Breastfeeding Duration to Weaning or 6 Months 2. Breastfeeding Exclusivity to Weaning or 6 months 3. Survey of Breastfeeding Problems and Outcomes Data Collection Ended 11/2012 n=27

NICU Experimental Recruited as of June 10th, 2012 N=21 Order Supplies and Set up Clinic Began July 2012 Recruit 30 Mothers of infants EGA 31-36 who are less than 8 days old End by 7/31/2013 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 third month Data Collection: Mothers followed via phone calls for 6 months from infant's birth for these outcomes: 1. Breastfeeding Duration to Weaning or 6 Months 2. Breastfeeding Exclusivity to Weaning or 6 months 3. Survey of Breastfeeding Problems and Outcomes End By 12/2013 Recruited as of June 10th, 2012 N=21

Breastfeeding Rate Definitions *Exclusive: defined as only human milk without the addition of other fluids or solids with the exception of those that are medically prescribed. **Weaned is defined as no longer receiving human milk via breast or supplementation for 1 week. ***Month was defined as at least 3 weeks

Socioeconomic Data* Complete for Control and To Date for Treatment Comparison of the Control and Treatment Groups Values Control Treatment N= 27 mothers* 31 infants* 21 mothers* 24 infants* Gender % 52% (15/29) Girls 38% (14/29) Boy 37.5% (9/24) Girls 62.5 % (15/24) Boys NVSD Delivery % 50% (12/24) 61.9% (13/21) Birth # Single=23 Twins=4 Single=18 Twins=3 Gravity/Parity Range G= 1-10 P= 1-9 G= 1-5 P= 1-4 *Data Not Available for 3 in Control

Comparison of Mean Values for the Control and Treatment Groups Means Control Treatment* EGA Weeks 33.84 34.96 BW Grams 2358.5 2210.6 Maternal Age Years 28.9 28.67 Pre-partum Maternal Weight-Pounds 155.0 134.6 Gravity/Parity G= 2.75 P= 2.33 G= 2.1 P= 2.0 * Data as of 6/10/13 n=21

Comparison of Values for the Control and Treatment Groups Control n=27 Treatment* n=21 Lost to Follow-Up 18.5% (5/27) 2 at 2 months and 1 at 3, 4 and 6 mo 1 NPO for 2 mo 3 Declined/Not Qualified 14.3% (3/21) 1 at 2 mo, 2 by 3 mo, 3 by 4-6 mo 1 NPO for 2 mo*** 10+ Declined/Not Qualified # Completed Program 23/27 (4 mo) 22/27 (6 mo) 21/21 (1 mo) 15/17 (2 mo) 14/16 (3 mo) Prenatal BF Duration Goals* n=23/27 Range 1-24 Mo Mean 8.5 Mo* Range 0-12 Mo Mean 9.2 Mo Prenatal BF Exclusivity Goals n=20/27 74% (20/27) Had Goals 85% (17/20) With Goals Completed Pilot 57.1%=12/21 Had Goals N/A With Goals Completed Pilot Censored Duration Goals (For Those Completing the Pilot) n=19/23 Mean 5.24 mo** Mean 5.5 mo** Actual Goals Met for Those Completing the Program 3.4 Mean Months or 65.3% of Goal N/A *Some moms gave a range of months in this case the mean value was used to compute overall mean **Used Maximum Duration Goal of 6 months for those with longer goals because data only collected to 6 months ***NPO but colostrum care started—should this be considered feeding exclusively human milk?

CONTROL GROUP: Number and Percent Who Did Not Meet, Met or Exceeded Their Duration Goals UNMET 10/19 (53%) 5/10 (50%) had goals of> 6 months MET 9/19 (47%) 7/9 (78%) had goals of 6 month or more EXCEEDED 2/19 (10%) exceed goals 2/2 had goals of <3 months)

Major Barriers Encountered Any Problem % Low Milk Supply Latching/Sucking or Breast Refusal Breast Inflammation or Nipple Pain Control n=27 (Moms) n=31 Infants 85.2 Mother 64.5 Infant 70.4 Both 78.6 Mothers 61.0 Unresolved 4.0 Relapsed 46.7 Infants 36.6 Unresolved 29.69 Mothers 0.037 Unresolved Case n=21 (Moms) n=24 (Infants) 71.4 Mother 50.0 Infant 42.9 Both 71.4 Mothers 14.3 Unresolved 19.0 Relapsed 37.5 Infants 8.1 Unresolved 38.1 Mothers 0.04 Unresolved

Mismanagement Barriers Inadequate Pumping Equipment Flange Too Small Tongue-Ties Provider Knowledge Deficits Control 11.1% n= 1/27 WIC Repossessed n=1/27 D/C w/out Electric .037% (n=1/27) 0% reported 14.8% (n=3/27) 1/27 CLE or CLC(?) told no Tx For LMS after 4-6 weeks 2/27 MD advised to wean for safe med Case 23.8% n=3/21 No Pump Coverage n=2/21 D/C w/out Electric 28.6% (n=6/21) 11% (n=2/18)* 28.5% (n=6/21) 1/21 MD’s advised to wean for safe med 1/21 MD weight mismanagement 1/21 IBCLC undx ductal infection 1/21 NICU untx nipple retraction 1/21 NICU inappropriate supplementation 1/21 MD misdx milk allergy *3 Dyads never examined

Problem Survey Report 3 dyads never examined % Other Problems Reported Problems Reported by <2 Mothers Control 11.5% Oversupply or Over Active Let Down 10.0% Colic 10.0% Sleepy Fatigued or Low Tone 1 infant Medication Problem 2 Little Time or Stressed 1 Mother Hospitalized 1 Nipple Confusion 1 Poor Weight Gain 2 Infants Hospitalized (RSV) 2 Constipation Case 14.2% Sleepy Baby 14.2% Poor Weight Gain 2 Retracting/Flat Nipple 1 Infant ER visit for Respiratory Distress 3 dyads never examined 50% did not attend an appt.

Infant Problems Latch Problems and Breastfeeding Rate Outcomes Unresolved Resolved Other Control (n=16/31) n=9* 100% (n=8/8) BF< 3 mo n=4 100% (n=4/4) BF>3 mo 100% (n=3/3) BF>5 mo 2 Used Nipple Shield w/out Supervision Case (n= 9/24) n=3 100% (3/3) BF<3 mo n=6 100% (n=3/3) BF>3 mo*** All 3 unresolved latches were infants of poorly motivated 16 year old mothers * 1 Dropped out at 1 mo **1 dropped out at 3 mo and 1 at 5 mo *** 3 not yet 3 months of age

Problems Continued CONTROL CASE 3 Developed LMS after D/C 3 Mothers reported using galactogogues 1 Reglan (metaclopramide) 3 Fenugreek CASE 9 LMS in-hospital 6 LMS after D/C 8 (38%) Mothers treated with Reglan (metaclopramide) 6 responded (1 not a candidate d/t PPD) 5 treated with fenugreek At least 7 with transportation problems

Comparison of Control vs Case Milk Supply at Discharge P Value Test >16 oz 37.0% 66.7% 0.08 Fisher’s Two-tailed Mean Mother 358.7 ml 647.0 ml 0.006 Two-Tailed t test Mean Infant 323.5 ml 565.8 ml 0.04

Comparison of Control and Case Group Durations of Any and Exclusive Nursing for 1, 2, and 3 months

Control Data for 4-6 Months 4 Months (n=23/27) Any=43.5% Exclusive=17.4% 5 Months (n=23/27) Any=39% Exclusive=137%* 6 Months (n=22/27) Any=36% Exclusive=4.5%** *1 or **2 were predominantly breastfeeding were not included (they were only supplementing 2-3 times per week—one because of low milk supply and the other for convenience)

Milk Supply at Discharge and Percent Still Breastfeeding By Month Control <400 cc’s 15 81.3%* (13/16) 53.3%* (8/15) 21.4% (3/14) 7.1% (1/14) Case <400 cc’s 5 75%* 3/4 25%* 1/4 25% 0% 0/4 Both <400 cc’s 20 80% 16/20 47% 9/19 22% 4/18 5.5% 1/18 Control >400 cc’s 11 100% (11/11) (8/10) 78% (7/9) Case >400 cc’s 10 10/10 89% 8/9 7/9 43% 3/7 29% 2/7 Both >400 cc’ 21 21/21 95% 19/20 90% 18/20 60% 12/18 59% 10/17 53% 9/17 * 1 NPO

Percent Breastfeeding Based on D/C Milk Supply > or < 400 cc’s

Control Group: RR of being weaned by Month if Supply <400cc’s vs > 400cc's 1 mo 1.21 [0.92, 1.58] p = 0.16 2 mo 1.80 [1.12, 2.90] p = 0.01 3 mo 4.11 [1.63, 10.36] p = 0.004 4 mo 5.60 [1.50, 20.96] p = 0.01 5-6 mo 10.89 [1.60, 74.32] p = 0.02

Conclusions Before Discharge: Breastfeeding Durations and Exclusivity will not improve unless 1 or more of the following occur: Before Discharge: Hospitalized Dyads have access to prompt and convenient care by a PCP who specializes in breastfeeding NICU’s provide transportation for maternal visitation NICU’s provide each mother with a hospital grade pump that the mother can use at home and at the bedside until discharge After Discharge: Transportation is provided to Appointments and/or Home Visits are an option Lactation Consultants are readily available at all Well Baby appointments and/or Health Care Providers learn to manage breastfeeding or dyads are managed by a Breastfeeding Medicine Specialist

Future Research Suggestions 1. Reward mothers who are still pumping at D/C with their own double-electric pump 2. Adapt the “Baby-Friendly” criteria for the NICU 3. 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 ingested C) The effects of maternal rooming-in 48 hours prior to D/C 4. Provide cell phones for better communication and lower loss-to-follow-up 5. Offer Incentives to improve compliance with visits Future Research Suggestions

Questions?