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JaundiceNCT00966719

Breastfeeding Support Intervention in Jaundiced Infants

A study testing Lactation Consultant support in people with Jaundice and Breastfeeding, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

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

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. Read more about this study

Who is it for?
Ages Up to 1 month
Conditions the study is for
Jaundice, Breastfeeding
What is being tested?
Lactation Consultant support
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
99 participants
Where
1 siteCanada
Study dates
Oct 2009to Apr 2013
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 Up to 1 month
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario, K1H8L1

Other trials in Canada

About this study

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.

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.

Read the detailed description

1.1 Overview This study will assess the effectiveness of a breastfeeding support intervention for infants admitted to the hospital with jaundice. It will evaluate the effect of this intervention on duration of breastfeeding and health care utilization.

1.2 Study Objectives: Primary: To determine the effect of a breastfeeding support intervention on breastfeeding duration in breastfeeding infants admitted to the hospital with jaundice.

Secondary:

  • To determine the rate of breastfeeding failure, defined as breastfeeding cessation before the infant turns 6 months, in mothers of jaundiced infants randomized to the control group, as compared to the rate of breastfeeding failure in the general population.
  • To compare subsequent healthcare utilization between groups during their first six months of life, as determined by the number of re-hospitalizations for jaundice, hospitalizations for non-jaundice related causes, as well as physician encounters.
  • To determine the number of mothers seeking breastfeeding help once discharged from the hospital and compare it between both groups.
  • To determine the kind and perceived effectiveness of breastfeeding support and advice given by the infant's primary physician throughout the child's first six months of life.

2.1 Summary: Breastfeeding confers many advantages to infants, mothers, families, and society in general. There is strong evidence that human milk feeding decreases the incidence of many infectious diseases and enhances the immunologic status of the newborn. It has been associated with enhanced performance on neurocognitive development tests, and has also been shown to provide important health benefits to the mother, including a decrease in risk of breast and ovarian cancers. It should be strongly encouraged for the first six months of life, and then continued for up to 2 years and beyond, as recommended in the World Health Organization's Innocent Declaration.

Neonatal jaundice is the most common problem in full-term infants during the immediate post-natal period. There is controversy as to whether breastfeeding increases the incidence of jaundice in the first days of life. In a study conducted in Italy, neonatal jaundice was not associated with breastfeeding per se, but rather with increased weight loss after birth subsequent to fasting, which can be seen with inadequate lactation.

When an infant is hospitalized, previously established patterns of breastfeeding are difficult to maintain. There is evidence to suggest that mothers of young infants admitted to hospital with hyperbilirubinemia commonly experience guilt as they feel breastfeeding caused the jaundice. Many of these women struggle with feelings of failure or inadequacy. A study recently conducted by the principal investigator of this current study (CP) suggested that infants admitted to the hospital with hyperbilirubinemia may have a higher rate of breastfeeding discontinuation than babies in the general population.

Previous studies have shown that breastfeeding support offered to various groups of mother-infant pairs significantly increased rates of breastfeeding at 2 to 6 months of age.

Given the clear health, social and economic advantages that breastfeeding confers to mothers, infants, and society in general, there is a need to assess the effectiveness of a breastfeeding support intervention for infants admitted to the hospital with jaundice.

2.2 Benefits of breastfeeding Breastfeeding is preferred for all infants, and exclusive breastfeeding of infants is recommended for the first 6 months after birth. Research has shown that human milk feeding decreases the incidence of multiple illnesses including bacterial meningitis, bacteremia, diarrhea, respiratory tract infection, otitis media, and urinary tract infections. A recent study conducted in Spain showed that exclusive breastfeeding lowered the risk of hospitalization as a result of infectious diseases during the first year of life. In that study, each additional month of exclusive breastfeeding would have avoided 30% of hospital admissions. A meta-analysis of 33 studies examining healthy infants in developed nations showed similar results, with formula-fed infants experiencing a tripling in severe respiratory illnesses compared with those who were exclusively breastfed for 4 months. Based on these results, breastfeeding promotion can lead to important economical gains from a societal perspective.

According to the most recent Ottawa Public Health Survey, breastfeeding rates in the general population are as follows: 91% of women initiate breastfeeding, with 56% practicing exclusive breastfeeding (no fluids other than breast milk). At 3 months, 71% of women continue to breastfeed, with 50% doing exclusive breastfeeding. This number drops to 60% for any breastfeeding at 6 months, with 39% of women exclusively breastfeeding.

2.3 Breastfeeding in hospitalized children Published reports have shown that previously established patterns of breastfeeding are hard to maintain once an infant is hospitalized. Moreover, as mentioned, evidence suggests that mothers of infants admitted to the hospital with jaundice experience guilt, as well feelings of failure and inadequacy as they often feel responsible for the child's admission to hospital. Maternal confidence has been shown to be a strong predictor of breastfeeding duration, with lack of confidence in breastfeeding skills leading to a higher likelihood of weaning in the first six weeks post-partum. There is only one study in the literature examining the rates of breastfeeding in the jaundiced population, which was done by the PI of this current study. Surveys were sent to all mothers of eligible infants admitted with jaundice to the Children's Hospital of Eastern Ontario (CHEO) over a 2.5 year period. One hundred and twenty-eight (64%) out of the 200 eligible mothers returned a completed survey. Of those, 92% had a post-secondary education. Information was collected, retrospectively, on length of breastfeeding after discharge from the hospital. Length of breastfeeding for hospitalized infants was compared to that of the Ottawa population, as reported by the City of Ottawa Public Health survey in 2005. Although numbers were the same between the jaundiced group and the City of Ottawa group, it is likely that the high education level of the study participants falsely elevated the rate of breastfeeding in the jaundiced infants. As mentioned, 92% of study participants had completed a post-secondary education, as compared to 53% of women involved in the population-based survey. Given that previous reports have shown that women with lower levels of education are more likely to discontinue breastfeeding early, it is reasonable to postulate that for comparable levels of education, mothers of infants admitted to the hospital with jaundice discontinue breastfeeding earlier than women in the general population.

2.4 Breastfeeding support interventions There are very few studies quantifying the effects of breastfeeding promotion interventions. A recent Cochrane review found that both professional and lay support were effective in prolonging breastfeeding. More specifically, this review found that professional support had more of an impact than lay support on both partial and exclusive breastfeeding and lay support affected exclusive breastfeeding. A review of four randomized controlled trials combining breastfeeding support with educational programs in developed countries found that combined education and support strategies increased short-term breastfeeding rates by 36%. Short-term breastfeeding in these studies was described as anywhere between 2 to 6 months. The education interventions were primarily conducted by lactation specialists or nurses as antepartum sessions, while the support interventions varied between telephone or in-person conversations, hospital or home visits by lactation consultants, nurses or peer counselors, and combined prearranged appointments and unscheduled visits or telephone calls for problems. Breastfeeding education and support had the biggest effect on initiation and maintenance of breastfeeding. Many of the studies however lacked scientific rigor. Most studies did not make a difference between exclusive and partial breastfeeding. Details regarding description and length of interventions as well as training of the individual delivering the educational session were often lacking.

A recent randomized controlled trial evaluating the effectiveness of a breastfeeding promotion intervention in the Republic of Belarus19 found an absolute increase of almost 37% in the prevalence of exclusive breastfeeding at 3 months in the intervention group. The chief obstetrician from each intervention maternity hospital, and the chief pediatrician from each intervention polyclinic, received the same 18-hour courses emphasizing methods to maintain lactation, promote exclusive and prolonged breastfeeding, and resolve common problems. All midwives, nurses and physicians providing care to study mothers and infants, as well as all pediatricians and nurses working in the polyclinics were trained over a period of 12 to 16 months. Such a program offered the advantage of providing reliable and consistent support, with the goal of being widely available. This study was published after the Cochrane review and thus is not included in the review.

Although no study published to date has determined which aspect of a breastfeeding support intervention yields positive results, it is likely to result from a combination of factors. Breastfeeding support results in increased confidence, and maternal confidence is known to be a strong predictor of breastfeeding outcome, with lack of confidence in breastfeeding skills leading to a higher likelihood of weaning in the first six weeks post-partum.

2.5 Availability of breastfeeding support In the recent CHEO study, 57% of the participating mothers needed to seek breastfeeding support after discharge from the hospital, suggesting they did not receive adequate help while hospitalized. Half of these women received help from private lactation consultants. These lactation consultants have variable training and may or may not hold recognized certifications or credentials. Their fees also vary from 10$ to 90$ an hour, and therefore may not be a suitable alternative for families with financial difficulties. This indicates the need for a standardized breastfeeding support intervention that will be accessible to all.

2.6 Breastfeeding and health care professionals Many studies have shown that physicians and physicians in training lack the necessary skills to offer proper guidance to lactating mothers. Freed et al surveyed pediatric residents and practitioners about breastfeeding knowledge and found that both groups had considerable knowledge deficits, and were ill-prepared for counseling mothers with lactation difficulties. Many residents surveyed in a study performed by Hillenbrand et al believed that early supplementation was not a cause of breast-feeding failure, although previous studies have clearly demonstrated this relationship. In the Ottawa study, only 3.9% of women reported receiving breastfeeding help from the treating physician while admitted to the hospital, suggesting the possibility that physicians do not have adequate knowledge to assess proper breastfeeding methods and counsel appropriately.

In summary, there is a need for this comprehensive study examining the impact of a breastfeeding support intervention for mothers of infants admitted to the hospital with jaundice. This study will clarify the rates of early breastfeeding discontinuation in the jaundiced population and help determine whether physicians in the Ottawa population have knowledge deficits when it comes to breastfeeding, as there may be a role for incorporating teaching of breastfeeding skills to physicians and physicians in training.

Being tested
Lactation Consultant support
Keywords
Jaundice, Breastfeeding, Infants
Medical subject headings
Jaundice, Breast Feeding

What participants receive

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

  • Lactation Consultant supportOther

    Also called Breastfeeding 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.

Study groups in NCT00966719
Study groupRoleWhat they receive
Lactation ConsultantActive comparatorIn hospital meeting with lactation consultant 1 to 3 follow up visits at weekly intervals with lactation consultant
Receives: Other: Lactation Consultant support
current treatment for jaundiceNo interventionBabies will receive current standard of care for jaundice (IV fluids and phototherapy)

What is being measured

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

  1. Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely

    Exclusive breastfeeding was defined as no milk intake other than breast milk

    Measured: 3 months

Secondary outcomes (7)
  1. Number of Participants Exclusively Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely

    Exclusive breastfeeding was defined as no milk intake other than breast milk

    Measured: 6 months

  2. Number of Participants Partially Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely

    Partial breastfeeding was defined as any feeding of breast milk

    Measured: 3 months

  3. Number of Participants Partially Breastfeeding at 6 Months, or 6 Months Corrected if the Infant Was Born Prematurely

    Partial breastfeeding was defined as any amount of feeding breast milk

    Measured: 6 months

  4. Number of Participants With an Infant Re-hospitalized for Jaundice

    Measured: 6 months

  5. Number of Participants With an Infant Re-hospitalized for Non-jaundice Related Causes in the First Six Months of Life

    Measured: 6 months

  6. Number of Physician Encounters in First 6 Months of Life

    Measured: 6 months

  7. Number of Mothers Seeking Breastfeeding Help

    Measured: 6 months

Timeline

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

  1. First posted27 Aug 2009 (estimated)
  2. Study startOct 2009
  3. Primary completionJan 2013
  4. Study completionApr 2013

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
99 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00966719
Sponsor's protocol ID
09/23E
Status last verified
Apr 2019
First submitted
26 Aug 2009
Last updated
17 Apr 2019
Data monitoring committee
No

Publications

  • Gartner LM, Morton J, Lawrence RA, Naylor AJ, O'Hare D, Schanler RJ, Eidelman AI; American Academy of Pediatrics Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2005 Feb;115(2):496-506. doi: 10.1542/peds.2004-2491.

    PubMed 15687461
  • 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. doi: 10.1016/s0031-3955(05)70288-1.

    PubMed 11236719
  • Horwood LJ, Fergusson DM. Breastfeeding and later cognitive and academic outcomes. Pediatrics. 1998 Jan;101(1):E9. doi: 10.1542/peds.101.1.e9.

    PubMed 9417173
  • Anderson JW, Johnstone BM, Remley DT. Breast-feeding and cognitive development: a meta-analysis. Am J Clin Nutr. 1999 Oct;70(4):525-35. doi: 10.1093/ajcn/70.4.525.

    PubMed 10500022
  • 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. doi: 10.1056/NEJM199401133300201.

    PubMed 8259187
  • 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. doi: 10.1016/S0140-6736(02)09454-0.

    PubMed 12133652
  • 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. doi: 10.1093/ije/22.2.192.

    PubMed 8505173
  • 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. doi: 10.1542/peds.107.3.e41.

    PubMed 11230622
  • 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. doi: 10.1001/archpedi.1983.02140320037007.

    PubMed 6846290
  • Schneider AP 2nd. Breast milk jaundice in the newborn. A real entity. JAMA. 1986 Jun 20;255(23):3270-4.

    PubMed 3712679
  • 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. doi: 10.1159/000243979.

    PubMed 8260541
  • 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. doi: 10.1111/j.1651-2227.1987.tb10507.x.

    PubMed 3604669
  • 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.

    PubMed 12019058
  • 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.

    PubMed 20808472

Questions about this trial

What is this clinical trial studying?

A study testing Lactation Consultant support in people with Jaundice and Breastfeeding, run by Children's Hospital of Eastern Ontario at 1 site in Canada.

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 2 inclusion and 11 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 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

Yes. Results are posted in the registry (first posted 28 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Exclusively Breastfeeding at 3 Months, or 3 Months Corrected if the Infant Was Born Prematurely (time frame: 3 months). 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 NCT00966719, which also lists 45 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 17 Apr 2019.

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