Breastfeeding, ExclusiveNCT04572581
Donor Breast Milk and Breastfeeding Rates
A study testing Donor Breast Milk in people with Breastfeeding, Exclusive and Breastfeeding, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible. Read more about this study
- Who is it for?
- Ages Up to 3 days
- Conditions the study is for
- Breastfeeding, Exclusive, Breastfeeding
- What is being tested?
- Donor Breast Milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2020to 15 Aug 2022
- Phase
- Interventional
- 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 Up to 3 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age >34 weeks and 0 days
- Mother's intent to breast feed
- NICU admission which is predicted to be at least 72 hours from time of admission
Who cannot join
- Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
- Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
- Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
- Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
- Any infant whose care is considered futile by the primary medical team
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90025
Santa Monica-UCLA
Los Angeles, California, 90404
About this study
Official title: Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial
The purpose of this pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
Read the detailed description
In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Being tested
- Donor Breast Milk
- Keywords
- Late Preterm, Donor Breast Milk
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donor Breast MilkOther
Donor breast milk will be given to the newborn if supplementation is required
| Study group | Role | What they receive |
|---|---|---|
| Exclusively Human Milk Diet | Experimental | This group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation. Receives: Other: Donor Breast Milk |
| Formula-based Diet | No intervention | If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Feasibility_1
Feasibility will be evaluated by: consent rate
Measured: 6-8 weeks chronological age
Study Feasibility_2
Feasibility will be evaluated by: study completion rate
Measured: 6-8 weeks chronological age
Study Feasibility_3
Feasibility will be evaluated by: rate of adherence to the study diet.
Measured: 6-8 weeks chronological age
Secondary outcomes (7)
Percentage of Human Milk Consumption at Discharge
Maternal milk/total milk (percent) consumed by the neonate over 48 hours
Measured: at the time of NICU discharge or 7 days of age, whichever is later
Percentage of Human Milk Consumption After Discharge
Maternal milk/total milk (percent) consumed by the infant over 48 hours
Measured: 6-8 weeks chronological age
Breastfeeding duration
time infant received breastmilk since birth
Measured: 6-8 weeks chronological age
Intent to Breastfeed
Mother's desire to continue to breastfeed: specifically assessed by asking the mother if she plans to exclusively breastfeed or not. Answers will be recorded as yes or no.
Measured: 6-8 weeks chronological age
Growth: Weight
Weight in kilograms reported as a z-score
Measured: 6-8 weeks chronological age
Growth: Height
height in centimeters reported as a z-score
Measured: 6-8 weeks chronological age
Growth: Head Circumference
head circumference in centimeters reported as a z-score
Measured: 6-8 weeks chronological age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 Nov 2020
- Primary completion26 Jun 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara L. Calkins, MD, University of California, Los Angeles
- Investigators
- Kara L Calkins, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572581
- Sponsor's protocol ID
- 19-002179
- Status last verified
- Aug 2022
- First submitted
- 15 Sep 2020
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to make IPD available for other research given this is a small pilot feasibility study.
Publications
Adamkin DH. Feeding problems in the late preterm infant. Clin Perinatol. 2006 Dec;33(4):831-7; abstract ix. doi: 10.1016/j.clp.2006.09.003.
PubMed 17148007Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.
PubMed 19881390Backstrom MC, Aine L, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Maki M. Maturation of primary and permanent teeth in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F104-8. doi: 10.1136/fn.83.2.f104.
PubMed 10952702Cleaveland K. Feeding challenges in the late preterm infant. Neonatal Netw. 2010 Jan-Feb;29(1):37-41. doi: 10.1891/0730-0832.29.1.37.
PubMed 20085875Darcy AE. Complications of the late preterm infant. J Perinat Neonatal Nurs. 2009 Jan-Mar;23(1):78-86. doi: 10.1097/JPN.0b013e31819685b6.
PubMed 19209064DeMauro SB, Patel PR, Medoff-Cooper B, Posencheg M, Abbasi S. Postdischarge feeding patterns in early- and late-preterm infants. Clin Pediatr (Phila). 2011 Oct;50(10):957-62. doi: 10.1177/0009922811409028. Epub 2011 Aug 19.
PubMed 21856965Engle WA, Tomashek KM, Wallman C; Committee on Fetus and Newborn, American Academy of Pediatrics. "Late-preterm" infants: a population at risk. Pediatrics. 2007 Dec;120(6):1390-401. doi: 10.1542/peds.2007-2952.
PubMed 18055691Fein SB, Labiner-Wolfe J, Shealy KR, Li R, Chen J, Grummer-Strawn LM. Infant Feeding Practices Study II: study methods. Pediatrics. 2008 Oct;122 Suppl 2:S28-35. doi: 10.1542/peds.2008-1315c.
PubMed 18829828Gauer RL, Burket J, Horowitz E. Common questions about outpatient care of premature infants. Am Fam Physician. 2014 Aug 15;90(4):244-51.
PubMed 25250998Gianni ML, Bezze EN, Sannino P, Baro M, Roggero P, Muscolo S, Plevani L, Mosca F. Maternal views on facilitators of and barriers to breastfeeding preterm infants. BMC Pediatr. 2018 Aug 27;18(1):283. doi: 10.1186/s12887-018-1260-2.
PubMed 30149811Jain BK. Vitamin requirements of very low birth weight infants: a review. Indian J Matern Child Health. 1994 Apr-Jun;5(2):46-9.
PubMed 12318806Kalyoncu O, Aygun C, Cetinoglu E, Kucukoduk S. Neonatal morbidity and mortality of late-preterm babies. J Matern Fetal Neonatal Med. 2010 Jul;23(7):607-12. doi: 10.1080/14767050903229622.
PubMed 19757335Lapillonne A, O'Connor DL, Wang D, Rigo J. Nutritional recommendations for the late-preterm infant and the preterm infant after hospital discharge. J Pediatr. 2013 Mar;162(3 Suppl):S90-100. doi: 10.1016/j.jpeds.2012.11.058.
PubMed 23445854Lucas A, Morley R, Cole TJ, Gore SM. A randomised multicentre study of human milk versus formula and later development in preterm infants. Arch Dis Child Fetal Neonatal Ed. 1994 Mar;70(2):F141-6. doi: 10.1136/fn.70.2.f141.
PubMed 8154907Lucas A, Morley R, Cole TJ. Randomised trial of early diet in preterm babies and later intelligence quotient. BMJ. 1998 Nov 28;317(7171):1481-7. doi: 10.1136/bmj.317.7171.1481.
PubMed 9831573
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Human Milk-Based Diet in the Late Preterm and Term Infant in the Neonatal Intensive Care Unit: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04572581
- Acronym / sponsor ID
- 19-002179
- Conditions
- Breastfeeding, Exclusive, Breastfeeding
- Keywords
- Late Preterm, Donor Breast Milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 26 Jun 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 1 Oct 2020 (actual)
- 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 pilot study is to determine if a randomized controlled study comparing a human milk diet versus a formula supplemented diet in late preterm and term infants in the neonatal intensive care unit (NICU) is feasible.
Detailed description
In late preterm infants and term neonates in the NICU whose mothers intend to breastfeed, this pilot study seeks to 1. determine study feasibility (consent rate, study completion rate, and rate of adherence to study diet), and 2. determine whether a dietary supplementation with donor human milk vs. formula improves: a. the percentage of maternal milk consumption at time of discharge from the NICU, or 7 days of age, whichever is later, b. breastfeeding rates and intent to breastfeed at 6-8 weeks chronological age, and c. breast feeding duration.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exclusively Human Milk Diet | Experimental | Other: Donor Breast MilkThis group will receive human milk only. If the mother is not producing enough breast milk, this group will receive donor milk supplementation. |
| Formula-based Diet | No intervention | –If the mother is not producing enough breast milk, this group will receive formula supplementation (the standard of care). |
Who may qualify
- Ages
- Up to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Gestational age >34 weeks and 0 days
- Mother's intent to breast feed
- NICU admission which is predicted to be at least 72 hours from time of admission
Key exclusion criteria (5 listed)
- Confirmed genetic disorders and syndromes or other disorders known to affect growth and ability to bottle feed or breast feed (i.e., Trisomies)
- Common neonatal congenital anomalies (cardiac disease, congenital gastrointestinal disorders, etc)
- Commonly accepted contraindications for breast feeding (HIV, galactosemia, herpes lesions on the breast, maternal use of drugs that are considered contraindicated with breast feeding including marijuana)
- Infant admitted to the intensive care unit who is receiving invasive respiratory support (intubation) and/or ionotropic medications
- Any infant whose care is considered futile by the primary medical team
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 |
|---|---|---|
| Donor Breast MilkDonor breast milk will be given to the newborn if supplementation is required | Other | Exclusively Human Milk Diet |
Primary outcome
Study Feasibility_1
Time frame: 6-8 weeks chronological age
Feasibility will be evaluated by: consent rate
Study Feasibility_2
Time frame: 6-8 weeks chronological age
Feasibility will be evaluated by: study completion rate
Study Feasibility_3
Time frame: 6-8 weeks chronological age
Feasibility will be evaluated by: rate of adherence to the study diet.
7 secondary outcomes
Percentage of Human Milk Consumption at Discharge
Time frame: at the time of NICU discharge or 7 days of age, whichever is later
Percentage of Human Milk Consumption After Discharge
Time frame: 6-8 weeks chronological age
Breastfeeding duration
Time frame: 6-8 weeks chronological age
Intent to Breastfeed
Time frame: 6-8 weeks chronological age
Growth: Weight
Time frame: 6-8 weeks chronological age
Growth: Height
Time frame: 6-8 weeks chronological age
Growth: Head Circumference
Time frame: 6-8 weeks chronological age
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 1 Sep 2022.
- Background: PubMed 17148007Adamkin DH. Feeding problems in the late preterm infant. Clin Perinatol. 2006 Dec;33(4):831-7; abstract ix. doi: 10.1016/j.clp.2006.09.003.
- Background: PubMed 19881390Agostoni C, Buonocore G, Carnielli VP, De Curtis M, Darmaun D, Decsi T, Domellof M, Embleton ND, Fusch C, Genzel-Boroviczeny O, Goulet O, Kalhan SC, Kolacek S, Koletzko B, Lapillonne A, Mihatsch W, Moreno L, Neu J, Poindexter B, Puntis J, Putet G, Rigo J, Riskin A, Salle B, Sauer P, Shamir R, Szajewska H, Thureen P, Turck D, van Goudoever JB, Ziegler EE; ESPGHAN Committee on Nutrition. Enteral nutrient supply for preterm infants: commentary from the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition. J Pediatr Gastroenterol Nutr. 2010 Jan;50(1):85-91. doi: 10.1097/MPG.0b013e3181adaee0.
- Background: PubMed 10952702Backstrom MC, Aine L, Maki R, Kuusela AL, Sievanen H, Koivisto AM, Ikonen RS, Maki M. Maturation of primary and permanent teeth in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2000 Sep;83(2):F104-8. doi: 10.1136/fn.83.2.f104.
- Background: PubMed 20085875Cleaveland K. Feeding challenges in the late preterm infant. Neonatal Netw. 2010 Jan-Feb;29(1):37-41. doi: 10.1891/0730-0832.29.1.37.
- Background: PubMed 19209064Darcy AE. Complications of the late preterm infant. J Perinat Neonatal Nurs. 2009 Jan-Mar;23(1):78-86. doi: 10.1097/JPN.0b013e31819685b6.
- Background: PubMed 21856965DeMauro SB, Patel PR, Medoff-Cooper B, Posencheg M, Abbasi S. Postdischarge feeding patterns in early- and late-preterm infants. Clin Pediatr (Phila). 2011 Oct;50(10):957-62. doi: 10.1177/0009922811409028. Epub 2011 Aug 19.
- Background: PubMed 18055691Engle WA, Tomashek KM, Wallman C; Committee on Fetus and Newborn, American Academy of Pediatrics. "Late-preterm" infants: a population at risk. Pediatrics. 2007 Dec;120(6):1390-401. doi: 10.1542/peds.2007-2952.
- Background: PubMed 18829828Fein SB, Labiner-Wolfe J, Shealy KR, Li R, Chen J, Grummer-Strawn LM. Infant Feeding Practices Study II: study methods. Pediatrics. 2008 Oct;122 Suppl 2:S28-35. doi: 10.1542/peds.2008-1315c.
- Background: PubMed 25250998Gauer RL, Burket J, Horowitz E. Common questions about outpatient care of premature infants. Am Fam Physician. 2014 Aug 15;90(4):244-51.
- Background: PubMed 30149811Gianni ML, Bezze EN, Sannino P, Baro M, Roggero P, Muscolo S, Plevani L, Mosca F. Maternal views on facilitators of and barriers to breastfeeding preterm infants. BMC Pediatr. 2018 Aug 27;18(1):283. doi: 10.1186/s12887-018-1260-2.
- Background: PubMed 12318806Jain BK. Vitamin requirements of very low birth weight infants: a review. Indian J Matern Child Health. 1994 Apr-Jun;5(2):46-9.
- Background: PubMed 19757335Kalyoncu O, Aygun C, Cetinoglu E, Kucukoduk S. Neonatal morbidity and mortality of late-preterm babies. J Matern Fetal Neonatal Med. 2010 Jul;23(7):607-12. doi: 10.1080/14767050903229622.
- Individual participant dataSharing planned: No. There is no current plan to make IPD available for other research given this is a small pilot feasibility study.
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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.
Kara L Calkins, MD principal investigator
University of California, Los Angeles
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Donor Breast Milk in people with Breastfeeding, Exclusive and Breastfeeding, run by University of California, Los Angeles at 2 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 3 inclusion and 5 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Study Feasibility_1 (time frame: 6-8 weeks chronological age). The study lists 3 primary outcomes in all. 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 NCT04572581, which also lists 29 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 1 Sep 2022.