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| Name | Class |
|---|---|
| Centre for Infectious Disease Research in Zambia | OTHER |
| Chiesi Foundation | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-volume breastmilk | Other | Preterm infants will be given high-volume breastmilk |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | Average change in weight between enrolment (baseline) up to 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first. | Baseline up to 40 weeks PMA. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline up to 40 weeks PMA. |
| Mid-arm circumference |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal mortality | Newborn status at 28 days after birth | 28 days after birth |
| Weight at 40 weeks PMA | For infants discharged prior to 40 weeks PMA, their birthweight will be taken at 40 weeks PMA during study exit. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldemar Carlo, MD | University of Alabama at Birmingham | Study Chair |
| Colm Travers, MD | University of Alabama at Birmingham | Study Director |
| Albert Manasyan, MD, MPH | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Teaching Hospital | Lusaka | 10101 | Zambia |
Study data will be shared upon a reasonable request to the study PI.
Data will be available for sharing following publication of study findings (or during submission for publication if requested by the journal)
Following a reasonable request to the study PI.
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.
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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. |
| 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. | 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. | 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. | 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 | Through study completion, on average 8 weeks after enrolment |
| 40 weeks PMA |
| Postpartum Depression | Maternal postpartum depression at at 6-8 weeks postnatally using Edinburgh Postnatal Depression Scale screening tool (scale ranges from 0-30, with 11+ indicative of depressive symptoms) | 6-8 weeks postnatal |
| D000091642 | Urogenital Diseases |