Evidence map›Paper›PMID 38158697›Full record

ArticleJournal of human lactation : official journal of International Lactation Consultant Association2024

Study Protocol for a Stepped-Wedge Cluster (Nested) Randomized Controlled Trial of Antenatal Colostrum Expression (ACE) Instruction in First-Time Mothers: The ACE Study.

Cassandra Cuffe, Roslyn Giglia, Matthew N Cooper, Julie Hill, Desiree Silva, Anita M Moorhead, Valerie Verhasselt, Joshua R Lewis, Deborah Ireson, Jill R Demirci and 4 more

Open access · hybridAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of human lactation : official journal of International Lactation Consultant Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.6field-weighted citation impact, top 27% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors at 6 institutions in 2 countries.

Cassandra CuffeNutrition & Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.ORCID 0000-0003-0645-3089
Roslyn GigliaAdjunct Academic, Curtin University Kent St, Bentley WA, Australia.
Matthew N CooperTelethon Kids Institute, University of Western Australia, Perth Children's Hospital, Perth, WA, Australia.
Julie HillNutrition & Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.
Desiree SilvaTelethon Kids Institute, Perth, WA, Australia.
Anita M MoorheadLa Trobe University, Judith Lumley Centre, Melbourne, VIC, Australia.
Valerie VerhasseltTelethon Kids Institute, Perth, WA, Australia.
Joshua R LewisNutrition & Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.
Deborah IresonSchool of Nursing and Midwifery, Edith Cowan University, Bunbury, WA, Australia.
Jill R DemirciDepartment of Health Promotion & Development, School of Nursing, University of Pittsburgh, Pittsburgh, PA, USA.ORCID 0000-0002-4802-7849
Talea CotteArmadale Kalamunda Group, Armadale Hospital, Perth, WA, Australia.
Kathryn WebbNutrition & Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.
Frances PateyNutrition & Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.
Therese A O'SullivanNutrition & Health Innovation Research Institute, School of Medical and Health Sciences, Edith Cowan University, Joondalup, WA, Australia.
Edith Cowan University · AUThe Kids Research Institute Australia · AUArmadale Health ServiceCurtin University · AURoyal Women's Hospital · AUUniversity of Pittsburgh · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAlthough many mothers initiate breastfeeding, supplementation with human-milk substitutes (formula) during the birth hospitalization is common and has been associated with early breastfeeding cessation. Colostrum hand expressed in the last few weeks before birth, known as antenatal colostrum expression (ACE), can be used instead of human-milk substitutes. However, evidence is lacking on the efficacy of ACE on breastfeeding outcomes and in non-diabetic mothers. METHODS AND PLANNED ANALYSIS: This multicenter stepped-wedge cluster (nested) randomized controlled trial aims to recruit 945 nulliparous pregnant individuals. The trial is conducted in two phases. During Phase 1, control group participants are under standard care. During Phase 2, participants are randomized to ACE instruction via a pre-recorded online video or a one-on-one session with a midwife. Adjusted logistic regression analysis will be used to examine the relationship between ACE instruction and breastfeeding outcomes. RESEARCH AIMS AND QUESTIONS: Primary aim: (1) Does advising pregnant individuals to practice ACE and providing instruction improve exclusive breastfeeding rates at 4 months postpartum? Secondary research questions: (2) Do individuals who practice ACE have higher rates of exclusive breastfeeding during the initial hospital stay after birth? (3) Is teaching ACE via an online video non-inferior to one-on-one instruction from a midwife? (4) Does expressing colostrum in pregnancy influence time to secretory activation, or (5) result in any differences in the composition of postnatal colostrum? DISCUSSION: Trial findings have important implications for maternity practice, with the online video providing an easily accessible opportunity for ACE education as part of standard antenatal care.

Indexed as

Breast FeedingBreast Milk ExpressionColostrumFemaleHumansInfantMothersMulticenter Studies as TopicPregnancyPrenatal CareRandomized Controlled Trials as Topicantenatal colostrum expressionbreastfeedingformula feedinghuman milkhuman-milk substitutepregnancyrandomized controlled trialsecretory activationsupplementationThe ORIGINS Project

Identifiers

PMID38158697
PMCPMC10799540
OpenAlexW4390449955

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.