Human Milk/BreastfeedingNCT02692521
Human Milk Feeding Rates Post-NICU Discharge
An observational study of Human Milk/Breastfeeding, run by Pediatrix at 5 sites in United States.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Human Milk/Breastfeeding
- What is being tested?
- Human Milk
- How many people
- 1,160 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2016to 3 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: NICU Graduates
Who may be able to join
- Survival to discharge
- Site ability to plan and implement developmental follow-up for two years corrected age
Who cannot join
- Parents unwilling to participate in follow-up
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dallas Developmental Pediatrics
Dallas, Texas
Summerlin Developmental Clinic
Las Vegas, Nevada
San Antonio Pediatric Development Services
San Antonio, Texas
Developmental Follow-up Clinic - Scottsdale / Kidz Clinic II
Scottsdale, Arizona
Preemie Place High Risk Infant Follow-up Clinic
The Woodlands, Texas
About this study
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.
Read the 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.
- Conditions
- Human Milk/Breastfeeding
- Being tested
- Human Milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human MilkDietary supplement
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startMar 2016
- Primary completion3 Feb 2020
- Study completion3 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Human Milk/BreastfeedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pediatrix
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Ellis, MD, Principal investigator, Pediatrix
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692521
- Sponsor's protocol ID
- PDX-001-15
- Status last verified
- Jun 2020
- First submitted
- 17 Feb 2016
- Last updated
- 9 Jun 2020
- Results posted
- No
Publications
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.
PubMed 24689979Davanzo 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.
PubMed 19840296Furman L, Minich N, Hack M. Correlates of lactation in mothers of very low birth weight infants. Pediatrics. 2002 Apr;109(4):e57. doi: 10.1542/peds.109.4.e57.
PubMed 11927730Paula 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.
PubMed 22371471Fenrich AL, Shmorhun DP, Martin GC, Young JA, Cohen MI, Kelleher AS, Anyebuno MA, Rider ED, Motta CL, Clark RH. Long QT and Hearing Loss in High-Risk Infants Prospective Study Registry. Pediatr Cardiol. 2022 Dec;43(8):1898-1902. doi: 10.1007/s00246-022-02939-4. Epub 2022 Jun 3.
PubMed 35661239
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Milk Feeding Rates Post-NICU Discharge
- ClinicalTrials.gov ID
- NCT02692521
- Acronym / sponsor ID
- PDX-001-15
- Conditions
- Human Milk/Breastfeeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,160 participants (actual)
- Lead sponsor
- PediatrixUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 3 Feb 2020 (actual)
- Study completion
- 3 Feb 2020 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- NICU Graduates
Key inclusion criteria (2 listed)
- Survival to discharge
- Site ability to plan and implement developmental follow-up for two years corrected age
Key exclusion criteria (1 listed)
- Parents unwilling to participate in follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human Milk | Dietary supplement | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 24689979Briere 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.
- Background: PubMed 19840296Davanzo 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.
- Background: PubMed 11927730Furman L, Minich N, Hack M. Correlates of lactation in mothers of very low birth weight infants. Pediatrics. 2002 Apr;109(4):e57. doi: 10.1542/peds.109.4.e57.
- BackgroundPaula 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
- Background: PubMed 22371471Section 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.
- Derived from this study: PubMed 35661239Fenrich AL, Shmorhun DP, Martin GC, Young JA, Cohen MI, Kelleher AS, Anyebuno MA, Rider ED, Motta CL, Clark RH. Long QT and Hearing Loss in High-Risk Infants Prospective Study Registry. Pediatr Cardiol. 2022 Dec;43(8):1898-1902. doi: 10.1007/s00246-022-02939-4. Epub 2022 Jun 3.
Related trials for Human Milk/Breastfeeding
Recruiting
Effect of Prenatal and Postnatal Intervention Strategies on Breastfeeding Outcomes in Women With Excessive Weight (Ready, Set, Nourish Study)
Breastfeeding, Dietary Intervention
Active, not recruiting
Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk
Prematurity; Extreme, Feeding Disorder Neonatal
Recruiting
Effectiveness of a Counseling Program on Exclusive Breastfeeding Rates in a Primary Care Center
Growth & Development, Breastfeeding Satisfaction
RecruitingPhase 4
Pasteurised Donor Human Milk Supplementation for Term Babies
Neonatal Hypoglycemia, Metabolic Complication
Not yet recruiting
Vitamin A Supplementation and Breast Milk Vitamin A Levels in Mothers of Preterm Infants
Premature, Preterm Infant Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Ellis, MD principal investigator
Pediatrix
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Milk/Breastfeeding, run by Pediatrix at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify barriers and incentives to the use of human milk in infants hospitalized in a NICU (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02692521, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.