Breastfeeding Support Intervention in Jaundiced Infants

This study has been completed.

Sponsor:

Collaborator:

The Physicians' Services Incorporated Foundation

Information provided by (Responsible Party):

Children's Hospital of Eastern Ontario

ClinicalTrials.gov Identifier:

NCT00966719

First received: August 26, 2009

Last updated: January 28, 2016

Last verified: January 2016

History of Changes

Purpose

Breastfeeding decreases the risk of many infantile infectious diseases and certain types of cancers in women. It strengthens the bond between mothers and babies and decreases the health care cost to society by making children healthier. Although it is controversial, breastfeeding has been reported to increase the risk of jaundice in the neonatal period. There is some evidence that mothers of hospitalized jaundiced infants discontinue breastfeeding early, as they feel responsible for the baby's condition.

The main objective of this study is to determine the effect of a breastfeeding intervention on breastfeeding duration in jaundiced infants. All eligible infants will be randomized to one of two groups (an intervention or a control group). Mothers of infants in the intervention group will meet with a lactation consultant during their hospital stay, and three times post hospital discharge. Lactation consultants are individuals who have received certification in breastfeeding support from an international board, ensuring safe and effective practice. Mothers of infants in the control group will receive the current standard of care, which is typically support from the nursing staff, who are often not trained in lactation support. Information will be collected on length of time that infants are fed only breast milk, future visits to health care providers, mothers' need for breastfeeding support post hospital discharge, mothers' perception of their physicians' attitudes towards breastfeeding, and mothers' experiences at the hospital, as well as feedback on the intervention. Phone follow-up will occur one week post hospital discharge, and when the child is 2, 3, 4 and 6 months old.

The results of this study will clarify the importance of offering sound breastfeeding advice to mothers of young infants hospitalized with jaundice and help determine whether there is a need for trained lactation specialists in children's hospitals. It will allow us to examine whether such an intervention can have a quantifiable impact on children's health in their first 6 months of life, as measured by physician encounters and hospitalizations. It will also allow collection of information on advice and support given to breastfeeding women by primary care physicians, potentially identifying needs for more rigorous breastfeeding training during medical training.

Condition	Intervention
Jaundice Breastfeeding	Other: Lactation Consultant support


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator)
Official Title:	The Impact of a Breastfeeding Support Intervention on Breastfeeding Duration in Jaundiced Infants Admitted to a Tertiary Care Centre: a Randomized Controlled Trial.

Resource links provided by NLM:

MedlinePlus related topics: Breastfeeding Health Facilities

U.S. FDA Resources

Further study details as provided by Children's Hospital of Eastern Ontario:

Primary Outcome Measures:

Exclusive breastfeeding at 3 months, or 3 months corrected if the infant was born prematurely. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exclusive breastfeeding at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Partial breastfeeding at three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Partial breastfeeding at six months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of re-hospitalization for jaundice in the first six months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of re-hospitalization for non-jaundice related causes in the first six months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of physician encounters in first 6 months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Number of mothers seeking breastfeeding help [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Amount and type of breastfeeding support given by child's primary physician in first six months of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]


Enrollment:	99
Study Start Date:	October 2009
Study Completion Date:	April 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Lactation Consultant In hospital meeting with lactation consultant 1 to 3 follow up visits at weekly intervals with lactation consultant	Other: Lactation Consultant support Meeting with lactation consultant once while in hospital and up to 3 times after discharge, in addition to current standard of care for jaundice. Other Name: Breastfeeding support
No Intervention: current treatment for jaundice Babies will receive current standard of care for jaundice (IV fluids and phototherapy)

Show Detailed Description

Eligibility


Ages Eligible for Study:	up to 1 Month (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Mothers of infants admitted during the study period with hyperbilirubinemia, breastfeeding at the time of admission (any amount of breastfeeding)
Mothers of infants < 1 month of age at the time of admission

Exclusion Criteria:

Mothers of infants admitted with hyperbilirubinemia who are exclusively formula-fed
Mothers of infants with hyperbilirubinemia of the predominantly conjugated type as this is a different disease, not associated with breastfeeding difficulties
Mothers of infants with anatomical abnormalities, such as cleft lip or palate, as this would interfere with breastfeeding and require more intensive intervention.
Mothers of neurologically impaired infants as breastfeeding may be more difficult in this population
Mother of infants who were admitted to the Neonatal Intensive Care Unit (NICU) after birth and never went home as they are likely to have other comorbidities affecting feeding.
Mothers of infants feeding via naso-gastric, naso-jejunal, or gastric tube
Mothers of infants > 1 month of age
Mothers who have had breast surgery in the past
Foster mothers or adoptive mothers
Mothers who do not understand English or French
Mothers of infants that are the result of multiple birth (eg twins)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966719

Locations


Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H8L1

Sponsors and Collaborators

Children's Hospital of Eastern Ontario

The Physicians' Services Incorporated Foundation

Investigators


Principal Investigator:	Catherine M Pound, MD	Children's Hospital of Eastern Ontario and Research Institute

More Information

Publications:

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Heinig MJ. Host defense benefits of breastfeeding for the infant. Effect of breastfeeding duration and exclusivity. Pediatr Clin North Am. 2001 Feb;48(1):105-23, ix. Review.

Horwood LJ, Fergusson DM. Breastfeeding and later cognitive and academic outcomes. Pediatrics. 1998 Jan;101(1):E9.

Anderson JW, Johnstone BM, Remley DT. Breast-feeding and cognitive development: a meta-analysis. Am J Clin Nutr. 1999 Oct;70(4):525-35.

Newcomb PA, Storer BE, Longnecker MP, Mittendorf R, Greenberg ER, Clapp RW, Burke KP, Willett WC, MacMahon B. Lactation and a reduced risk of premenopausal breast cancer. N Engl J Med. 1994 Jan 13;330(2):81-7.

Collaborative Group on Hormonal Factors in Breast Cancer. Breast cancer and breastfeeding: collaborative reanalysis of individual data from 47 epidemiological studies in 30 countries, including 50302 women with breast cancer and 96973 women without the disease. Lancet. 2002 Jul 20;360(9328):187-95.

Rosenblatt KA, Thomas DB. Lactation and the risk of epithelial ovarian cancer. The WHO Collaborative Study of Neoplasia and Steroid Contraceptives. Int J Epidemiol. 1993 Apr;22(2):192-7.

UNICEF-WHO. Innocenti Declaration. On the Protection, Promotion and Support of Breast-feeding. New York, NY:UNICEF;1990.

Bertini G, Dani C, Tronchin M, Rubaltelli FF. Is breastfeeding really favoring early neonatal jaundice? Pediatrics. 2001 Mar;107(3):E41.

Maisels MJ, Gifford K. Neonatal jaundice in full-term infants. Role of breast-feeding and other causes. Am J Dis Child. 1983 Jun;137(6):561-2.

Schneider AP 2nd. Breast milk jaundice in the newborn. A real entity. JAMA. 1986 Jun 20;255(23):3270-4. Erratum in: JAMA 1986 Dec 19;256(23):3218.

Rubaltelli FF. Unconjugated and conjugated bilirubin pigments during perinatal development. IV. The influence of breast-feeding on neonatal hyperbilirubinemia. Biol Neonate. 1993;64(2-3):104-9.

Nielsen HE, Haase P, Blaabjerg J, Stryhn H, Hilden J. Risk factors and sib correlation in physiological neonatal jaundice. Acta Paediatr Scand. 1987 May;76(3):504-11.

Willis SK, Hannon PR, Scrimshaw SC. The impact of the maternal experience with a jaundiced newborn on the breastfeeding relationship. J Fam Pract. 2002 May;51(5):465.

Pound CM, Gaboury I. The impact of jaundice in newborn infants on the length of breastfeeding. Paediatr Child Health. 2009 Sep;14(7):445-9.

Guise JM, Palda V, Westhoff C, Chan BK, Helfand M, Lieu TA; U.S. Preventive Services Task Force. The effectiveness of primary care-based interventions to promote breastfeeding: systematic evidence review and meta-analysis for the US Preventive Services Task Force. Ann Fam Med. 2003 Jul-Aug;1(2):70-8. Review.

Kramer MS, Chalmers B, Hodnett ED, Sevkovskaya Z, Dzikovich I, Shapiro S, Collet JP, Vanilovich I, Mezen I, Ducruet T, Shishko G, Zubovich V, Mknuik D, Gluchanina E, Dombrovskiy V, Ustinovitch A, Kot T, Bogdanovich N, Ovchinikova L, Helsing E; PROBIT Study Group (Promotion of Breastfeeding Intervention Trial). Promotion of Breastfeeding Intervention Trial (PROBIT): a randomized trial in the Republic of Belarus. JAMA. 2001 Jan 24-31;285(4):413-20.

Canadian Paediatric Society, Dietitians of Canada and Health Canada. Nutrition for Healthy Term Infants. 1998. Ottawa: Minister of Public Works and Government Services, 1998

Health Canada. Exclusive Breastfeeding Duration: 2004 Health Canada Recommendation. Ottawa, 2004. www.hc-sc.gc.ca/hpfb-dgpsa/onpp-bppn/exclusive_breastfeeding_duration_e.html

World Health Organization. Global Strategy for Infant and Young Child Feeding, The Optimal Duration of Exclusive Breastfeeding. Geneva, 2001. www.who.int/gb/ebwha/pdf_files/WHA54/ea54id4.pdf

Cochi SL, Fleming DW, Hightower AW, Limpakarnjanarat K, Facklam RR, Smith JD, Sikes RK, Broome CV. Primary invasive Haemophilus influenzae type b disease: a population-based assessment of risk factors. J Pediatr. 1986 Jun;108(6):887-96.

Istre GR, Conner JS, Broome CV, Hightower A, Hopkins RS. Risk factors for primary invasive Haemophilus influenzae disease: increased risk from day care attendance and school-aged household members. J Pediatr. 1985 Feb;106(2):190-5.

Takala AK, Eskola J, Palmgren J, Rönnberg PR, Kela E, Rekola P, Mäkelä PH. Risk factors of invasive Haemophilus influenzae type b disease among children in Finland. J Pediatr. 1989 Nov;115(5 Pt 1):694-701.

Dewey KG, Heinig MJ, Nommsen-Rivers LA. Differences in morbidity between breast-fed and formula-fed infants. J Pediatr. 1995 May;126(5 Pt 1):696-702.

Howie PW, Forsyth JS, Ogston SA, Clark A, Florey CD. Protective effect of breast feeding against infection. BMJ. 1990 Jan 6;300(6716):11-6.

Popkin BM, Adair L, Akin JS, Black R, Briscoe J, Flieger W. Breast-feeding and diarrheal morbidity. Pediatrics. 1990 Dec;86(6):874-82.

López-Alarcón M, Villalpando S, Fajardo A. Breast-feeding lowers the frequency and duration of acute respiratory infection and diarrhea in infants under six months of age. J Nutr. 1997 Mar;127(3):436-43.

Bachrach VR, Schwarz E, Bachrach LR. Breastfeeding and the risk of hospitalization for respiratory disease in infancy: a meta-analysis. Arch Pediatr Adolesc Med. 2003 Mar;157(3):237-43.

Oddy WH, Sly PD, de Klerk NH, Landau LI, Kendall GE, Holt PG, Stanley FJ. Breast feeding and respiratory morbidity in infancy: a birth cohort study. Arch Dis Child. 2003 Mar;88(3):224-8.

Duncan B, Ey J, Holberg CJ, Wright AL, Martinez FD, Taussig LM. Exclusive breast-feeding for at least 4 months protects against otitis media. Pediatrics. 1993 May;91(5):867-72.

Aniansson G, Alm B, Andersson B, Håkansson A, Larsson P, Nylén O, Peterson H, Rignér P, Svanborg M, Sabharwal H, et al. A prospective cohort study on breast-feeding and otitis media in Swedish infants. Pediatr Infect Dis J. 1994 Mar;13(3):183-8.

Mårild S, Hansson S, Jodal U, Odén A, Svedberg K. Protective effect of breastfeeding against urinary tract infection. Acta Paediatr. 2004 Feb;93(2):164-8.

Pisacane A, Graziano L, Zona G. Breastfeeding and urinary tract infection. Lancet. 1990 Jul 7;336(8706):50.

Paricio Talayero JM, Lizán-García M, Otero Puime A, Benlloch Muncharaz MJ, Beseler Soto B, Sánchez-Palomares M, Santos Serrano L, Rivera LL. Full breastfeeding and hospitalization as a result of infections in the first year of life. Pediatrics. 2006 Jul;118(1):e92-9.

City of Ottawa, Ottawa Public Health. Infant Care Survey 2005

Britton C, McCormick FM, Renfrew MJ, Wade A, King SE. Support for breastfeeding mothers. Cochrane Database Syst Rev. 2007 Jan 24;(1):CD001141. Review. Update in: Cochrane Database Syst Rev. 2012;5:CD001141.

Freed GL, Clark SJ, Sorenson J, Lohr JA, Cefalo R, Curtis P. National assessment of physicians' breast-feeding knowledge, attitudes, training, and experience. JAMA. 1995 Feb 8;273(6):472-6.

Williams EL, Hammer LD. Breastfeeding attitudes and knowledge of pediatricians-in-training. Am J Prev Med. 1995 Jan-Feb;11(1):26-33.

Hillenbrand KM, Larsen PG. Effect of an educational intervention about breastfeeding on the knowledge, confidence, and behaviors of pediatric resident physicians. Pediatrics. 2002 Nov;110(5):e59.

Olson CM, Psiaki DL. Imparting information on breastfeeding to medical students. J Med Educ. 1978 Oct;53(10):845-7.

Wright A, Rice S, Wells S. Changing hospital practices to increase the duration of breastfeeding. Pediatrics. 1996 May;97(5):669-75.

Sadeharju K, Knip M, Virtanen SM, Savilahti E, Tauriainen S, Koskela P, Akerblom HK, Hyöty H; Finnish TRIGR Study Group. Maternal antibodies in breast milk protect the child from enterovirus infections. Pediatrics. 2007 May;119(5):941-6.

Wright AL, Holberg CJ, Martinez FD, Morgan WJ, Taussig LM. Breast feeding and lower respiratory tract illness in the first year of life. Group Health Medical Associates. BMJ. 1989 Oct 14;299(6705):946-9.

von Kries R, Koletzko B, Sauerwald T, von Mutius E, Barnert D, Grunert V, von Voss H. Breast feeding and obesity: cross sectional study. BMJ. 1999 Jul 17;319(7203):147-50.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pound CM, Moreau K, Rohde K, Barrowman N, Aglipay M, Farion KJ, Plint AC. Lactation support and breastfeeding duration in jaundiced infants: a randomized controlled trial. PLoS One. 2015 Mar 6;10(3):e0119624. doi: 10.1371/journal.pone.0119624. eCollection 2015.


Responsible Party:	Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier:	NCT00966719 History of Changes
Other Study ID Numbers:	09/23E
Study First Received:	August 26, 2009
Last Updated:	January 28, 2016
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Children's Hospital of Eastern Ontario:


Jaundice Breastfeeding Infants

Additional relevant MeSH terms:


Jaundice Hyperbilirubinemia Pathologic Processes Skin Manifestations Signs and Symptoms

ClinicalTrials.gov processed this record on September 26, 2016

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