Human Milk Feeding Rates Post-NICU Discharge

Human Milk/Breastfeeding Clinical Trial

Official title:

Human Milk Feeding Rates Post-NICU Discharge

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02692521
• Other study ID #: PDX-001-15
• Status: Completed
• Start date: March 2016
• Est. completion date: February 3, 2020

Study information

• Verified date: June 2020
• Source: Mednax Center for Research, Education, Quality and Safety
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to discover the incentives and barriers to human milk use and breast-feeding in the NICU graduate. By better understanding the incentives and barriers we believe we can define better methods for promoting higher rates and longer duration of human milk use in this medically fragile population.

Description:

The AAP continues to reaffirm its recommendation of exclusive breast feeding for about 6 months, with continuation of breastfeeding as complementary feeding starts. Ideally, breastfeeding continues for the first year of life. NICUs have implemented increasing use of human milk with reports of more than 80 percent of infants receiving at least some human milk at discharge. Research has shown that breastfeeding rates in preterm infants and initiation of breastfeeding at discharge are far less than that of term infants (Mastrup, 2014). Yet studies continue to show the ongoing benefits of breast milk initiation in low birth weight neonates while they are in the NICU and better developmental outcomes at 30 months of age (Vohr, Poindexter, Dusick, McKinley, et al., 2007). A large cohort of low birth weight infants studied revealed that those who were given breast milk early in their hospitalization and continued receiving it , whether expressed or breast fed, had less frequent re-hospitalizations and higher Bayley Developmental scores for emotional regulation at 30 months of age. Additionally, as their breast milk volume exposure increased, these children had improved mental development index and total behavioral index improvement as well.

In a CQI survey done in three NICU follow up clinics, we discovered that only about 30 percent were still breastfeeding at 1-3 months post discharge. There are a few studies investigating factors which contribute to increased human milk post discharge. Factors studied include kangaroo care, quick access to pumping support, and history of breast feeding while in the NICU.

There are a few studies investigating factors which contribute to increased human milk use post discharge. Callen and Pinelli found that successful breast feeding in preterm infants (mean gestation 28 weeks) was more likely in mothers who pumped early and continued diligently. In addition to early pumping and lactation support, kangaroo care, and having the experience of breast feeding while still in the NICU have been associated with longer use of human milk and successful breast feeding after discharge. Pineda (2011) looked at the effects of breast-feeding while in the NICU and whether the first oral sucking feeding was at the breast in preterm infants. Mean gestational age when the infant was put to breast was 33.1 weeks + 1.59 weeks. Though challenging for mothers, the ability to continue to maintain breast-feeding during the NICU stay and until discharge as well as having the first feed be at the breast increased overall duration of breast-feeding duration after discharge. Direct breast-feeding also increases oxytocin levels in the mother, which leads to psychological benefits such as improved maternal response and improved attachment behaviors. These factors may indirectly lead to improved use of breast milk.

This study will investigate which babies are receiving human milk, either expressed or breast fed at varying times post discharge, and further explores NICU factors which may foster or inhibit increasing breast milk use in NICU graduates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1160
• Est. completion date: February 3, 2020
• Est. primary completion date: February 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Survival to discharge

• Site ability to plan and implement developmental follow-up for two years corrected age

Exclusion Criteria:

• Parents unwilling to participate in follow-up

Related Conditions & MeSH terms

• Human Milk/Breastfeeding

Intervention

Dietary Supplement:
• Human Milk

Locations

Country	Name	City	State
United States	Dallas Developmental Pediatrics	Dallas	Texas
United States	Summerlin Developmental Clinic	Las Vegas	Nevada
United States	San Antonio Pediatric Development Services	San Antonio	Texas
United States	Developmental Follow-up Clinic - Scottsdale / Kidz Clinic II	Scottsdale	Arizona
United States	Preemie Place High Risk Infant Follow-up Clinic	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mednax Center for Research, Education, Quality and Safety

Country where clinical trial is conducted

United States, 

References & Publications (5)

Briere CE, McGrath J, Cong X, Cusson R. An integrative review of factors that influence breastfeeding duration for premature infants after NICU hospitalization. J Obstet Gynecol Neonatal Nurs. 2014 May-Jun;43(3):272-81. doi: 10.1111/1552-6909.12297. Epub 2014 Apr 1. Review. — View Citation

Davanzo R, Ronfani L, Brovedani P, Demarini S; Breastfeeding in Neonatal Intensive Care Unit Study Group. Breast feeding very-low-birthweight infants at discharge: a multicentre study using WHO definitions. Paediatr Perinat Epidemiol. 2009 Nov;23(6):591-6. doi: 10.1111/j.1365-3016.2009.01068.x. — View Citation

Furman L, Minich N, Hack M. Correlates of lactation in mothers of very low birth weight infants. Pediatrics. 2002 Apr;109(4):e57. — View Citation

Paula P. Meier, RN, DNSc, FAAN, Janet L. Engstrom, RN, PhD, CNM, WHNP-BC, Aloka L. Patel, MD, Briana J. Jegier, PhD, and Nicholas E. Bruns, Improving the Use of Human Milk During and After the NICU Stay. BSPublished online February 27, 2012 4Pediatrics Vol. 129 No. 3 March 1, 2012 pp. e827-e841 doi: 10.1542/peds.2011-3552

Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify barriers and incentives to the use of human milk in infants hospitalized in a NICU	Increase human milk use in post-NICU neonates by identifying barriers and incentives to the use of human milk in infants hospitalized in a NICU in order to maximize its use.	2 years