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NICU Control

This material is based on work supported by NIH under Prime Award no. UL1 RR031985 and The Regents of the University of California. 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.

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NICU Control

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  1. This material is based on work supported by NIH under Prime Award no. UL1 RR031985 and The Regents of the University of California This material is based on work supported by NIH under Prime Award no. UL1 RR031985 and The Regents of the University of California.

  2. NICU Control Submit Proposal to IRB Recruitment Started Feb 2012 n=27 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

  3. 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

  4.  *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

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

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

  7. Comparison of Values for the Control and Treatment Groups Control n=27 Control n=27 Values Treatment* n=21 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* Range 1-24 Mo Mean 8.5 Mo* Range 0-12 Mo Mean 9.2 Mo n=23/27 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) Mean 5.24 mo** Mean 5.5 mo** n=19/23 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?

  8. Major Barriers Encountered Any Low Milk Supply % Latching/Sucking or Breast Refusal % Breast Inflammation or Nipple Pain % Problem % 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

  9. Inadequate Pumping Equipment 11.1% Inadequate Pumping Equipment Flange Too Small .037% (n=1/27) Flange Too Small Tongue Ties Tongue- - Ties Provider Knowledge Deficits Provider Knowledge Deficits Control 0% reported 14.8% (n=3/27) n= 1/27 WIC Repossessed n=1/27 D/C w/out Electric 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

  10. % Other Problems Reported 11.5% Oversupply or Over Active Let Down 10.0% Colic 10.0% Sleepy Fatigued or Low Tone % Other Problems Reported Problems Reported by Mothers 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 2 Retracting/Flat Nipple 1 Infant ER visit for Respiratory Distress Problems Reported by < <2 Mothers 2 Control Case 14.2% Sleepy Baby 14.2% Poor Weight Gain •3 dyads never examined •50% did not attend an appt.

  11. Latch Problems and Breastfeeding Rate Outcomes Unresolved Control (n=16/ 31) Latch Problems and Breastfeeding Rate Outcomes Resolved n=4 100% (n=4/4) BF>3 mo 100% (n=3/3) BF>5 mo Other 2 Used Nipple Shield w/out Supervision n=9* 100% (n=8/8) BF< 3 mo 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 * 1 Dropped out at 1 mo **1 dropped out at 3 mo and 1 at 5 mo *** 3 not yet 3 months of age

  12. o ? CONTROL ◦ 3 Developed LMS after D/C ◦ 3 Mothers reported using galactogogues  1 Reglan (metaclopramide)  3 Fenugreek o 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 CONTROL CASE

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

  14. 100.0% 95.2% Any Case Any Case 88.5% 90.0% Any Control Any Control 80.0% 75.0% 70.6% Exclusive Case Exclusive Case 70.0% Exclusive Control Exclusive Control 60.0% 58.3% 60.0% 56.3% 50.0% 42.3% 40.0% 31.3% 29.4% 30.0% 25.0% 20.8% 20.0% 10.0% 0.0% 1 Month 2 Month 3 month

  15. 100.0% Control Data for 4-6 Months 90.0%  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%** 80.0% 70.0% 60.0% 50.0% 41.7% Duration 37.5% 40.0% 34.8% Exclusivity 30.0% 16.7% 20.0% 12.5% 10.0% 4.3% 0.0% 4 Months 5 Months 6 Months *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)

  16. Milk Supply Milk Supply n= n= 1 Month 1 Month 2 Month 2 Month 3 Month 3 Month 4 Month 4 Month 5 Month 5 Month 6 Month 6 Month 15 81.3%* (13/16) 75%* 3/4 80% 16/20 100% (11/11) 100% 10/10 100% 21/21 53.3%* (8/15) 25%* 1/4 47% 9/19 100% (11/11) 89% 8/9 95% 19/20 * 1 NPO 21.4% (3/14) 25% 1/4 22% 4/18 100% (11/11) 78% 7/9 90% 18/20 7.1% (1/14) 0% 0/4 5.5% 1/18 80% (8/10) 43% 3/7 60% 12/18 7.1% (1/14) 0% 0/4 5.5% 1/18 78% (7/9) 43% 3/7 59% 10/17 7.1% (1/14) 0% 0/4 5.5% 1/18 78% (7/9) 29% 2/7 53% 9/17 Control <400 cc’s 5 Case <400 cc’s 20 Both <400 cc’s 11 Control >400 cc’s 10 Case >400 cc’s 21 Both >400 cc’

  17. 120.0% Control <400 cc’s Control <400 cc’s Case <400 cc’s Case <400 cc’s 100.0% 100.0% Both <400 cc’s Both <400 cc’s 95.0% 90.0% Control >400 cc’s Control >400 cc’s 80.0% 80.0% 80.0% Case >400 cc’s Case >400 cc’s Both >400 cc’ Both >400 cc’ 60.0% 60.0% 59.0% 53.0% 47.0% 47.0% 40.0% 22.0% 22.0% 20.0% 5.5% 5.5% 5.5% 5.5% 5.5% 5.5% 0.0% 1 Month 1 Month 2 Month 2 Month 3 Month 3 Month 4 Month 4 Month 5 Month 5 Month 6 Month 6 Month

  18. RR RR 12 10.89 10.89 10 8 6 5.6 5.6 RR 4.11 4.11 4 2 1.8 1.8 1.21 1.21 0 1 Month 2 Months 3 Months 4 Months 5-6 Months 1 mo 2 mo 3 mo 4 mo 5-6 mo 10.89 [1.60, 74.32] p = 0.02 1.21 [0.92, 1.58] p = 0.16 1.80 [1.12, 2.90] p = 0.01 4.11 [1.63, 10.36] p = 0.004 5.60 [1.50, 20.96] p = 0.01

  19. 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

  20. 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

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