Postnatal Growth RestrictionNCT05403684
Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
A study testing High-volume breastmilk in people with Postnatal Growth Restriction, run by University of Alabama at Birmingham at 1 site in Zambia.
Trial summary
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to… Read more about this study
- Who is it for?
- Ages 1 day to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Postnatal Growth Restriction
- What is being tested?
- High-volume breastmilk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteZambia
- Study dates
- 13 Jun 2022to 10 Feb 2023
- 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 1 day to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 28 0/7 to 31 6/7 weeks of age or weighing between 1000-1999 grams,
- Admitted to the UTH NICU within 24 hours after birth, and
- Infants who have reached feeding volume ≥120 mL/kg/day at time of randomization
Who cannot join
- Who are deemed unstable by the neonatologist,
- With necrotizing enterocolitis or intestinal perforation
- Known gastrointestinal malformations,
- Major malformations or congenital anomalies, and
- Whose parents do not provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to those given UV breastmilk (140-180 mL/kg/day).
Read the detailed description
The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences. The study will enrol a total of 214 study participants including 190 preterm infants randomized controlled trial of HV feedings and 24 mothers of enrolled infants and healthcare workers for in-depth interviews. We will also screen mothers to study participants for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) screening tool.
Study aims are:
Aim 1: To evaluate the impact of high volume (HV) feedings using additionally expressed milk at the end of feeding (hind-milk) vs usual volume (UV) feedings on growth velocity from birth to discharge or 40 weeks' PMA, whichever comes first, among very preterm infants.
Through a 1:1 randomization, the study will enrol 190 preterm infants weighing between 1,000g - 1,999g in both study arms and follow them until hospital discharge or 40 weeks' PMA, whichever comes first.
Aim 2: To evaluate the impact of HV vs UV breastfeeding until 40 weeks' PMA on all-cause neonatal mortality and morbidity (including sepsis, NEC, intestinal perforation, and hypoglycaemia).
All study participants (n=190) will be until 40 weeks' PMA to estimate its impact on all-cause neonatal mortality and morbidity.
Aim 3: To characterize the acceptability, feasibility, and feeding tolerance among HV breastfeeding women and their infants at the hospital and its feasibility by healthcare workers.
A total of 24 mothers and healthcare workers will be interviewed through in-depth interviews (IDIs) to better understand the acceptability of this intervention by the feeding mothers, the feeding tolerance by their newborns, and the feasibility of the same by the healthcare workers.
- Conditions
- Postnatal Growth Restriction
- Being tested
- High-volume breastmilk
- Keywords
- breastmilk, hindmilk, high-volume breastfeeding, postnatal growth restriction, preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-volume breastmilkOther
Preterm infants will be given high-volume breastmilk
| Study group | Role | What they receive |
|---|---|---|
| Usual-volume breastfeeding (UV Group) | No intervention | Infants will receive cup-feeding (to standardize the volume at each feeding) per standard of care guidelines (SOC: 140-180 mL/kg/day) with volumes adjusted for weight and infant age. |
| High-volume breastfeeding (HV Group) | Experimental | Along with SOC volume provided via cup-feeding, the mother will continue to express and feed the baby hind-milk reaching 240 mL/kg/day with volumes adjusted for weight and infant age (200-240 ml/kg/day). Receives: Other: High-volume breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight gain
Average change in weight between enrolment (baseline) up to 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
Measured: Baseline up to 40 weeks PMA.
Secondary outcomes (6)
Head circumference
Average change in head circumference (in centimetres using measuring tape) between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
Measured: Baseline up to 40 weeks PMA.
Mid-arm circumference
Average change in mid-arm circumference (in centimetres using measuring tape) between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
Measured: Baseline up to 40 weeks PMA.
Length
Average change in length (in centimetres using measuring tape) between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
Measured: Baseline up to 40 weeks PMA.
Length of hospital stay
Average change in length of hospital stay between enrolment (baseline) and 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
Measured: Baseline up to 40 weeks PMA.
Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants
To characterize the acceptability, feasibility, and feeding tolerance among HV breastfeeding women and their infants at the hospital.
Measured: Through study completion, on average 8 weeks after enrolment
Characterise feasibility of HV breastfeeding by healthcare workers (HCWs)
To characterize the feasibility of HV breastmilk by mothers to the infants (patients) by HCWs
Measured: Through study completion, on average 8 weeks after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start13 Jun 2022
- Primary completion28 Dec 2022
- Study completion10 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postnatal Growth RestrictionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences.
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Chiesi Foundation
- Responsible party
- Principal investigator, Albert Manasyan, MD, MPH, University of Alabama at Birmingham
- Investigators
- Waldemar Carlo, MD, Study chair, University of Alabama at BirminghamColm Travers, MD, Study director, University of Alabama at BirminghamAlbert Manasyan, MD, MPH, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403684
- Sponsor's protocol ID
- IRB-300007476
- Status last verified
- Feb 2023
- First submitted
- 23 May 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be shared upon a reasonable request to the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Hindmilk on Weight Gain Among Moderate to Very Preterm Infants in Zambia
- ClinicalTrials.gov ID
- NCT05403684
- Acronym / sponsor ID
- IRB-300007476
- Conditions
- Postnatal Growth Restriction
- Keywords
- breastmilk, hindmilk, high-volume breastfeeding, postnatal growth restriction, preterm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Centre for Infectious Disease Research in Zambia, Chiesi Foundation
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 28 Dec 2022 (actual)
- Study completion
- 10 Feb 2023 (actual)
- First posted
- 3 Jun 2022 (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 primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to those given UV breastmilk (140-180 mL/kg/day).
Detailed description
The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences. The study will enrol a total of 214 study participants including 190 preterm infants randomized controlled trial of HV feedings and 24 mothers of enrolled infants and healthcare workers for in-depth interviews. We will also screen mothers to study participants for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS) screening tool.
Study aims are:
Aim 1: To evaluate the impact of high volume (HV) feedings using additionally expressed milk at the end of feeding (hind-milk) vs usual volume (UV) feedings on growth velocity from birth to discharge or 40 weeks' PMA, whichever comes first, among very preterm infants.
Through a 1:1 randomization, the study will enrol 190 preterm infants weighing between 1,000g - 1,999g in both study arms and follow them until hospital discharge or 40 weeks' PMA, whichever comes first.
Aim 2: To evaluate the impact of HV vs UV breastfeeding until 40 weeks' PMA on all-cause neonatal mortality and morbidity (including sepsis, NEC, intestinal perforation, and hypoglycaemia).
All study participants (n=190) will be until 40 weeks' PMA to estimate its impact on all-cause neonatal mortality and morbidity.
Aim 3: To characterize the acceptability, feasibility, and feeding tolerance among HV breastfeeding women and their infants at the hospital and its feasibility by healthcare workers.
A total of 24 mothers and healthcare workers will be interviewed through in-depth interviews (IDIs) to better understand the acceptability of this intervention by the feeding mothers, the feeding tolerance by their newborns, and the feasibility of the same by the healthcare workers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The proposed study is a non-blinded randomized controlled trial with a 1:1 parallel allocation of infants to higher-volume feedings (200-240 ml/kg/day) or usual-volume feedings (140-180 ml/kg/day) using computer-generated random-block sequences.
| Arm | Type | Receives |
|---|---|---|
| Usual-volume breastfeeding (UV Group) | No intervention | –Infants will receive cup-feeding (to standardize the volume at each feeding) per standard of care guidelines (SOC: 140-180 mL/kg/day) with volumes adjusted for weight and infant age. |
| High-volume breastfeeding (HV Group) | Experimental | Other: High-volume breastmilkAlong with SOC volume provided via cup-feeding, the mother will continue to express and feed the baby hind-milk reaching 240 mL/kg/day with volumes adjusted for weight and infant age (200-240 ml/kg/day). |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 28 0/7 to 31 6/7 weeks of age or weighing between 1000-1999 grams,
- Admitted to the UTH NICU within 24 hours after birth, and
- Infants who have reached feeding volume ≥120 mL/kg/day at time of randomization
Key exclusion criteria (5 listed)
- Who are deemed unstable by the neonatologist,
- With necrotizing enterocolitis or intestinal perforation
- Known gastrointestinal malformations,
- Major malformations or congenital anomalies, and
- Whose parents do not provide informed consent
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 |
|---|---|---|
| High-volume breastmilkPreterm infants will be given high-volume breastmilk | Other | High-volume breastfeeding (HV Group) |
Primary outcome
Weight gain
Time frame: Baseline up to 40 weeks PMA.
Average change in weight between enrolment (baseline) up to 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
6 secondary outcomes
Head circumference
Time frame: Baseline up to 40 weeks PMA.
Mid-arm circumference
Time frame: Baseline up to 40 weeks PMA.
Length
Time frame: Baseline up to 40 weeks PMA.
Length of hospital stay
Time frame: Baseline up to 40 weeks PMA.
Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants
Time frame: Through study completion, on average 8 weeks after enrolment
Characterise feasibility of HV breastfeeding by healthcare workers (HCWs)
Time frame: Through study completion, on average 8 weeks after enrolment
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 14 Feb 2023.
- Individual participant dataSharing planned: Yes. Study data will be shared upon a reasonable request to the study PI.
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.
Waldemar Carlo, MD study chair
University of Alabama at Birmingham
Colm Travers, MD study director
University of Alabama at Birmingham
Albert Manasyan, MD, MPH principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-volume breastmilk in people with Postnatal Growth Restriction, run by University of Alabama at Birmingham at 1 site in Zambia.
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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. 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?
Weight gain (time frame: Baseline up to 40 weeks PMA.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2023.