N/A N=180 Randomized Treatment

Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants

Breast Milk Expression

Bottom Line

View on ClinicalTrials.gov: NCT01892085 ↗

Enrolled (actual)

180

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Pumped Milk Volume Day 1 — 3; 4; 5 mL — p=0.015

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Early initiation (Behavioral); Intermediate expression (Behavioral); Late initiation (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Aug 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Pumped Milk Volume Day 1	3; 4; 5	0.015 sig
PRIMARY Pumped Milk Volume on Day 2	11; 13; 15	0.024 sig
PRIMARY Pumped Milk Volume Day 3	31; 36; 41	0.031 sig
PRIMARY Pumped Milk Volume Day 4	73; 82; 94	0.05
PRIMARY Pumped Milk Volume on Day 5	145; 157; 180	0.069
PRIMARY Pumped Milk Volume Day 6	240; 253; 293	0.094
PRIMARY Pumped Milk Volume on Day 7	337; 343; 400	0.123
PRIMARY Pumped Milk Volume at Day 14	398; 391; 461	0.143
PRIMARY Pumped Milk Volume Day 21	396; 377; 447	0.185
PRIMARY Pumped Milk Volume Day 28	332; 305; 365	0.229
PRIMARY Pumped Milk Volume on Day 35	234; 209; 252	0.314
PRIMARY Pumped Milk Volume on Day 42	139; 120; 146	0.377
SECONDARY Hours From Birth to Onset of Lactogenesis Stage 2	140.5; 94.7; 109	0.08
SECONDARY Days Lactated	45.3; 48.7; 48.2	0.82
SECONDARY Percentage of Feeds Consisting of Mother's Own Milk Week 1	71.7; 69.2; 81.9	00.22
SECONDARY Percentage of Feeds Consisting of Mother's Own Milk Week 2 Consumed by Infants	65.7; 66.7; 70.2	0.87
SECONDARY Percentage of Feeds Consisting of Mother's Own Milk Week 3	55.7; 59.6; 70.2	0.27
SECONDARY Percentage of Feeds Consisting of Mother's Own Milk Week 4	57.5; 62.3; 64.5	0.77
SECONDARY Percentage of Feeds Consisting of Mother's Own Milk Week 5	51.8; 54.3; 65.6	0.31
SECONDARY Percentage of Feeds Consisting of Mother's Own Milk Week 6	51.1; 53.9; 56	0.90
SECONDARY Percentage of Feedings Consisting of Mother's Own Milk at NICU Discharge	82; 80; 90	0.36

Summary

Compelling evidence exists that breast milk helps protect very premature infants from prematurity-specific morbidities. Unfortunately, mothers of premature infants often exhibit delayed lactogenesis stage II (when the milk "comes in") and decreased breast milk production. Several studies have linked earlier initiation of breast milk expression following delivery with a greater milk production. However, none conclusively determined the optimal timing of breast milk expression. As a result these mothers continue to struggle with inadequate breast milk production. This study will follow 180 mothers of premature infants for 6 weeks following delivery to test Earlier initiation of breast milk expression following delivery is associated with (1) an earlier lactogenesis stage II, (2) greater volume of breast milk production during the first 6 weeks, (3) improved short-term infant health outcomes and (4) women who deliver at an earlier gestation will have decreased milk production and a later lactogenesis stage II. Following stratification according to the gestational age of the infant (23-27 weeks vs. 28-32 weeks), eligible women will be randomly assigned to one of three groups and instructed to start mechanically expressing their r breasts, either in the first hour, 1-3 hours or 3-6 hours following delivery. The timing of lactogenesis stage II will be documented, and the volume of breast milk produced will continue to be measured for the first 6 weeks following delivery and at discharge. Infant nutritional outcomes will be measured throughout the 6-week study. The impact of the differences in timing of initiation of milk expression following delivery on timing of lactogenesis stage II, milk volume, short term nutritional outcomes, amount of breast milk feedings at discharge, and impact of gestational age on milk volume and lactogenesis stage II will be determined.

Eligibility Criteria

Inclusion Criteria

1) at least 18 years of age,
2) English or Spanish-speaking,
3) stated intent to breastfeed,
4) anticipating the birth of a very low birth weight infant (≤1500 grams) between 23-32 weeks gestation.

Exclusion Criteria

1) known illicit maternal drug use,
2) history of breast reduction or augmentation,
3) positive HIV status,
4) mother not transported to recovery by 45 minutes following delivery or
5) infant not expected to live over 2 weeks following delivery.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01892085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.