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Prematurity; ExtremePAP-LMNCT06653595

Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)

A study testing Programme to Support Breastfeeding in people with Prematurity; Extreme and Prematurity, run by University of Barcelona at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. The intervention is performed by an Advanced Practice Nurse and International Board Certified Breastfeeding Consultant (IBCLC), with high expertise in breastfeeding… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Prematurity; Extreme, Prematurity
What is being tested?
Programme to Support Breastfeeding
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
2 sitesSpain
Study dates
13 Oct 2021to 20 Mar 2024
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 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Moderate premature
  • Late premature babies
  • Admitted to the NICU of Hospital Clínic
  • Single pregnancy
  • Families residing in the Barcelona Metropolitan Area (AMB)
  • Families with a good mental health
  • Families with a desire for Exclusive Breastfeeding up to 6 months

Who cannot join

  • Maternal diseases that contraindicate breastfeeding
  • Mothers with a history of breast surgery
  • Mothers with a history of severe hypogalactia
  • Premature babies with severe complications
  • Premature babies diagnosed with severe CIR

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

  • Rosselló 230

    Barcelona, 08008

  • C/Sabino de Arana, 1

    Barcelona, 08028

Other trials in Spain

About this study

Official title: Randomized Control Trial to Evaluate a Breastfeeding Support and Promotion Program to Improve the Health of Premature Babies (PAP-LM)

This study evaluates the effectiveness of a breastfeeding support and promotion program to increase exclusive breastfeeding rates in the preterm group. The intervention is performed by an Advanced Practice Nurse and International Board Certified Breastfeeding Consultant (IBCLC), with high expertise in breastfeeding problems. It is a combination of face-to-face, home care and telephone attention to improve the adherence to breastfeeding. The intervention lasts 6 months.

Read the detailed description

Will be included moderately premature infants to the Neonatal Unit of the Hospital Clínic who achieve with the inclusion criteria of the study. The sample calculation includes 162 subjects to increase breastfeeding rates to 70% at discharge, 50% at 3 months and 40% at 6 months of the babies. Mothers who wish to exclusively breastfeed up to 6 months and sign the informed consent, will be randomized into the experimental group or control group. The control group will receive usual care and the experimental group will receive 1 pre-discharge face-to-face session, 8 home care sessions up to 4 months and 3 telephone follow-up sessions up to 6 months of baby.

Being tested
Programme to Support Breastfeeding
Keywords
IBCLC, advance practice nurse, best practice, breastfeeding rates, breastfeeding outcomes, interventions
Medical subject headings
Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Programme to Support BreastfeedingOther

    The intervention consists of active support for breastfeeding by a lactation expert and IBCLC until the premature baby is 6 months old. The intervention includes: 1 face-to-face pre-discharge session, 8 home sessions up to 4 months and 3 telephone sessions up to 6 months.

Study groups in NCT06653595
Study groupRoleWhat they receive
CONTROL GROUPNo interventionThe Control Group receives the usual intervention from the health center, that consists in breastfeeding support in the NICU 1 time/week until hospital discharge.
EXPERIMENTAL GROUPExperimentalThe Experimental Group receives the PAP-LM programme.
Receives: Other: Programme to Support Breastfeeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BREASTFEEDING RATES

    Exclusive Breastfeeding or Parcial Breastfeeding

    Measured: 15 days postpartum, at 3 months and at 6 months postpartum

Secondary outcomes (5)

  1. PREMATURE GROWTH

    Kilograms, percentiles and Z-scores of weight

    Measured: 15 days postpartum, at 3 and 6 months postpartum

  2. PREMATURE HEIGHT

    Meters, percentiles and Z-scores of height

    Measured: 15 days postpartum, at 3 and 6 months postpartum

  3. PREMATURE CRANIAL PERIMETER

    Meters, percentiles and Z-scores of head circumference

    Measured: 15 days postpartum, at 3 and 6 months postpartum

  4. PUNTUATION IN DEVELOPMENT WITH ASQ-3

    Total puntuation in Ages And Stages Questionnarie of Development (ASQ-3)

    Measured: At 6 months postpartum

  5. MOTHER EFFICACY WITH BREASTFEEDING (USING BSES)

    The Breastfeeding Self-Efficacy Scale (BSES) is a tool that helps assess how confident a mother feels about her ability to breastfeed. Based on the idea that believing in yourself impacts success, the scale uses 14 questions to measure a mother's sense of capability in different breastfeeding tasks. The higher her score, the more confident she feels. This scale is commonly used by healthcare providers and researchers to better understand where mothers might need extra support, as confidence plays a key role in how long and how successfully they continue breastfeeding.

    Measured: 15 days postpartum and at 6 months postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2024
  2. Study start13 Oct 2021
  3. Primary completion15 Feb 2024
  4. Study completion20 Mar 2024

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
We will be use the random.org program to randomize families into two groups: experimental group (which will receive the intervention) and control group (which will receive usual care).The experimental group intervention will include: 1 pre-discharge face-to-face session, 8 home sessions until 4 months, and 3 telephone sessions until the baby is 6 months old. All sessions will be conducted by an Advanced Practice Nurse and IBCLC Expert in breastfeeding issues.
Masking
None (open label)
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06653595
Sponsor's protocol ID
HCB/2021/0595
Acronym
PAP-LM
Status last verified
Oct 2024
First submitted
5 Jun 2024
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The information will be confidential. Participation in the study will be voluntary and optional. Participants may leave the study at any time. No data or results will be transferred to patients.

Publications

  • Bonuck KA, Trombley M, Freeman K, McKee D. Randomized, controlled trial of a prenatal and postnatal lactation consultant intervention on duration and intensity of breastfeeding up to 12 months. Pediatrics. 2005 Dec;116(6):1413-26. doi: 10.1542/peds.2005-0435.

    PubMed 16322166

  • Bonuck K, Stuebe A, Barnett J, Labbok MH, Fletcher J, Bernstein PS. Effect of primary care intervention on breastfeeding duration and intensity. Am J Public Health. 2014 Feb;104 Suppl 1(Suppl 1):S119-27. doi: 10.2105/AJPH.2013.301360. Epub 2013 Dec 19.

    PubMed 24354834

  • Dias de Oliveira L, Justo Giugliani ER, Cordova do Espirito Santo L, Meirelles Nunes L. Counselling sessions increased duration of exclusive breastfeeding: a randomized clinical trial with adolescent mothers and grandmothers. Nutr J. 2014 Jul 17;13:73. doi: 10.1186/1475-2891-13-73.

    PubMed 25033743

  • Gross RS, Mendelsohn AL, Gross MB, Scheinmann R, Messito MJ. Randomized Controlled Trial of a Primary Care-Based Child Obesity Prevention Intervention on Infant Feeding Practices. J Pediatr. 2016 Jul;174:171-177.e2. doi: 10.1016/j.jpeds.2016.03.060. Epub 2016 Apr 21.

    PubMed 27113376

  • Hopkinson J, Konefal Gallagher M. Assignment to a hospital-based breastfeeding clinic and exclusive breastfeeding among immigrant Hispanic mothers: a randomized, controlled trial. J Hum Lact. 2009 Aug;25(3):287-96. doi: 10.1177/0890334409335482. Epub 2009 May 12.

    PubMed 19436060

  • Kools EJ, Thijs C, Kester AD, van den Brandt PA, de Vries H. A breast-feeding promotion and support program a randomized trial in The Netherlands. Prev Med. 2005 Jan;40(1):60-70. doi: 10.1016/j.ypmed.2004.05.013.

    PubMed 15530582

  • Nabulsi M, Tamim H, Shamsedine L, Charafeddine L, Yehya N, Kabakian-Khasholian T, Masri S, Nasser F, Ayash S, Ghanem D. A multi-component intervention to support breastfeeding in Lebanon: A randomized clinical trial. PLoS One. 2019 Jun 14;14(6):e0218467. doi: 10.1371/journal.pone.0218467. eCollection 2019.

    PubMed 31199849

  • O'Reilly SL, McNestry C, McGuinness D, Killeen SL, Mehegan J, Coughlan B, O'Brien EC, O'Brien D, Szafranska M, Brosnan M, Sheehy L, Murtagh R, O'Hagan L, Corbett M, Walsh M, Keogh R, Power P, Woodcock M, Phelan M, Carroll A, Murray S, Scallan C, Dunn E, McAuliffe FM. Multicomponent perinatal breastfeeding support in women with BMI >25: The Latch On multi-centre randomised trial. BJOG. 2024 Aug;131(9):1197-1206. doi: 10.1111/1471-0528.17782. Epub 2024 Feb 12.

    PubMed 38344894

  • Petrova A, Ayers C, Stechna S, Gerling JA, Mehta R. Effectiveness of exclusive breastfeeding promotion in low-income mothers: a randomized controlled study. Breastfeed Med. 2009 Jun;4(2):63-9. doi: 10.1089/bfm.2008.0126.

    PubMed 19239405

  • Tahir NM, Al-Sadat N. Does telephone lactation counselling improve breastfeeding practices? A randomised controlled trial. Int J Nurs Stud. 2013 Jan;50(1):16-25. doi: 10.1016/j.ijnurstu.2012.09.006. Epub 2012 Oct 17.

    PubMed 23084438

  • You H, Lei A, Xiang J, Wang Y, Luo B, Hu J. Effects of breastfeeding education based on the self-efficacy theory on women with gestational diabetes mellitus: A CONSORT-compliant randomized controlled trial. Medicine (Baltimore). 2020 Apr;99(16):e19643. doi: 10.1097/MD.0000000000019643.

    PubMed 32311936

  • Pascual-Tutusaus M, Manresa M, Migliorelli F, Arranz A, Biurrun-Garrido A, de Lamo-Camino M, Vidal-Carbo M, Goberna-Tricas J. Impact of a Lactation Consultant Support Program on Breastfeeding Rates, Infant Growth, and Morbidity: A Randomized Clinical Trial. J Perinat Neonatal Nurs. 2026 Jul 22. doi: 10.1097/JPN.0000000000001019. Online ahead of print.

    PubMed 42485498

Questions about this trial

What is this clinical trial studying?

A study testing Programme to Support Breastfeeding in people with Prematurity; Extreme and Prematurity, run by University of Barcelona at 2 sites in Spain.

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 7 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 22 Oct 2024. 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 Spain. 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?

BREASTFEEDING RATES (time frame: 15 days postpartum, at 3 months and at 6 months postpartum). 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 NCT06653595, which also lists 12 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 22 Oct 2024.

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