Human Milk Feeding Rates Post-NICU Discharge

Sponsor
Mednax Center for Research, Education, Quality and Safety (Other)
Overall Status
Completed
CT.gov ID
NCT02692521
Collaborator
(none)
1,160
5
47.1
232
4.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Human Milk

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
1160 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Human Milk Feeding Rates Post-NICU Discharge
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
Feb 3, 2020
Actual Study Completion Date :
Feb 3, 2020

Outcome Measures

Primary Outcome Measures

  1. Identify barriers and incentives to the use of human milk in infants hospitalized in a NICU [2 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Developmental Follow-up Clinic - Scottsdale / Kidz Clinic II Scottsdale Arizona United States
2 Summerlin Developmental Clinic Las Vegas Nevada United States
3 Dallas Developmental Pediatrics Dallas Texas United States
4 San Antonio Pediatric Development Services San Antonio Texas United States
5 Preemie Place High Risk Infant Follow-up Clinic The Woodlands Texas United States

Sponsors and Collaborators

  • Mednax Center for Research, Education, Quality and Safety

Investigators

  • Principal Investigator: Elaine Ellis, MD, Mednax Center for Research, Education, Quality and Safety

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mednax Center for Research, Education, Quality and Safety
ClinicalTrials.gov Identifier:
NCT02692521
Other Study ID Numbers:
  • PDX-001-15
First Posted:
Feb 26, 2016
Last Update Posted:
Jun 9, 2020
Last Verified:
Jun 1, 2020

Study Results

No Results Posted as of Jun 9, 2020