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Trial record 1 of 1 for:    NCT02692521
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Human Milk Feeding Rates Post-NICU Discharge

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02692521
Recruitment Status : Active, not recruiting
First Posted : February 26, 2016
Last Update Posted : October 17, 2019
Information provided by (Responsible Party):
Mednax Center for Research, Education, Quality and Safety

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
Human Milk/Breastfeeding 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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Human Milk Feeding Rates Post-NICU Discharge
Actual Study Start Date : March 2016
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Primary Outcome Measures :
  1. Identify barriers and incentives to the use of human milk in infants hospitalized in a NICU [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NICU Graduates

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02692521

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United States, Arizona
Developmental Follow-up Clinic - Scottsdale / Kidz Clinic II
Scottsdale, Arizona, United States
United States, Nevada
Summerlin Developmental Clinic
Las Vegas, Nevada, United States
United States, Texas
Dallas Developmental Pediatrics
Dallas, Texas, United States
San Antonio Pediatric Development Services
San Antonio, Texas, United States
Preemie Place High Risk Infant Follow-up Clinic
The Woodlands, Texas, United States
Sponsors and Collaborators
Mednax Center for Research, Education, Quality and Safety
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Principal Investigator: Elaine Ellis, MD Mednax Center for Research, Education, Quality and Safety
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Responsible Party: Mednax Center for Research, Education, Quality and Safety Identifier: NCT02692521    
Other Study ID Numbers: PDX-001-15
First Posted: February 26, 2016    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019