NCT Number: NCT02692521
Human Milk Feeding Rates Post-NICU Discharge
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.
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Notify MeKey information
Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Developmental Follow-up Clinic - Scottsdale / Kidz Clinic II, Scottsdale, Arizona, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Pediatrix
Other
Registry information
Important dates
- Study start
- 2016
- Primary completion
- 2020
- Study completion
- 2020
- First posted
- Feb 26, 2016
- Registry last updated
- Jun 9, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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